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The sponsor decided to terminate the study following an FDA request of a partial clinical hold.
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This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (melflufen+bortezomib+dex) | Experimental | Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with bortezomib at 1.3mg/m² S.Q. on Days 1, 4, 8, 11 and dexamethasone 20 mg (12 mg ≥ 75 years) Days 1, 4, 8, 11 and 40 mg (20 mg ≥ 75 years) on Day 15 and 22 of each 28-day cycle. |
|
| B (melflufen+daratumumab+dex) | Experimental | Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with daratumumab 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Dexamethasone p.o. 40 mg weekly (20 mg weekly for patients age ≥ 75 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan flufenamide (Melflufen) | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B:
| Cycle 1: Day 1 to Day 28 |
| Phase 2: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response (BR) | BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 hours, Partial Response (PR)= a > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by > 90% or to < 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of > 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable. |
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Inclusion Criteria:
Male or female, age 18 years or older
A prior diagnosis of multiple myeloma with documented disease progression in need of treatment at time of screening
One to four prior lines of therapy
Measurable disease defined as any of the following:
Life expectancy of ≥ 6 months
ECOG performance status ≤ 2. (Patients with lower performance status based solely on bone pain secondary to multiple myeloma may be eligible following consultation and approval of the medical monitor)
Patient is a female of childbearing potential (FCBP)* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control
Ability to understand the purpose and risks of the study and provide signed and dated informed consent
12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤ 470 msec
Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1:
Must have, or be willing to have an acceptable central catheter. (Port a cath, peripherally inserted central catheter [PICC] line, or central venous catheter)
Regimen A
Must be intolerant or refractory to a prior IMiD; refractory defined as failure to respond (MR or better) or progression while on therapy or within 60 days of last dose.
Regimen B
Must have had a prior IMiD and a proteasome inhibitor (PI); alone or in combination and must be refractory or intolerant to an IMiD, PI or both.
Exclusion Criteria:
Primary refractory disease (i.e. never responded with ≥ MR to any prior therapy)
Evidence of mucosal or internal bleeding and/or are platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after transfusion of an appropriate dose of platelets)
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ≥ Grade 3 thromboembolic event in the last 6 months)
Known active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of therapy
Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance
Pregnant or breast-feeding females
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
Known human immunodeficiency virus or active hepatitis B or C viral infection
Concurrent symptomatic amyloidosis or plasma cell leukemia
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy. The use of live vaccines within 30 days before initiation of therapy. IMiDs, PIs and or corticosteroids within 2 weeks prior to initiation of therapy. Other investigational therapies and monoclonal antibodies (mAb) within 4 weeks of initiation of therapy Prednisone up to but no more than 10 mg orally once daily (q.d.) or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy
Residual side effects to previous therapy > Grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy Grade 1 without pain are permitted)
Prior peripheral stem cell transplant within 12 weeks of initiation of therapy
Prior allogeneic stem cell transplantation with active graft-versus-host- disease
Prior major surgical procedure or radiation therapy within 4 weeks of initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy)
Known intolerance to the required dose and schedule of steroid therapy as determined by the investigator
Prior treatment with melflufen
Regimen A
Refractory to a PI in the last line of therapy prior to enrollment in this trial; refractory defined as failure to respond (MR or better) or progression while on therapy or within 60 days of last dose
History of allergic reaction/hypersensitivity attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate dihydrate
Regimen B
Prior exposure to an antiCD-38 mAb
Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
Moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
≥ Grade 3 conduction system abnormalities unless patient has a pacemaker
Active hepatitis B (defined as HBsAg+) or those at risk for reactivation (HBsAg-, Anti- HBs+, Anti-HBc+)
Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| The Ohio State University |
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A total of 56 participants were enrolled in the study, all of whom received study treatment.
56 participants were enrolled across 13 sites in the Czech Republic, France, Spain and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2021 | Oct 13, 2022 |
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| Dexamethasone | Drug | Oral tablets |
|
|
| Bortezomib | Drug | Subcutaneous administration |
|
|
| Daratumumab | Drug | Intravenous infusion |
|
|
| Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Duration of Response (DOR) | DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Time to Response (TTR) | Time from Cycle 1 Day 1 to a response of PR or better. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Progression-Free Survival (PFS) | PFS was defined as the time in months from date of initiation of therapy to the earlier of confirmed disease progression or death due to any cause. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Overall Survival (OS) | Time from the first dose of melflufen to death due to any cause. | Up to 24 months following confirmed disease progression, or initiation of subsequent therapy (a maximum of 198.9 weeks) |
| Duration of Clinical Benefit (DOCB) | DOCB was defined as time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Time to Progression (TTP) | TTP defined as time from first dose to first documented confirmed progression. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Clinical Benefit Rate (≥ Minimal Response) | ≥ Minimal response for participants included sCR, CR, VGPR, PR and MR. | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Time to Next Treatment (TTNT) | Defined as time from date of initiation of therapy to start of next line of therapy. | Until death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered. | Cycle 1 Day 1 up to a maximum of 198.9 weeks |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Fakultní nemocnice Brno | Brno | Czechia |
| Fakultní nemocnice Hradec Králové | Hradec Králové | Czechia |
| Fakultní nemocnice Ostrava | Ostrava | Czechia |
| Všeobecná fakultní nemocnice | Prague | Czechia |
| Hôpital Morvan | Brest | France |
| Centre Jean Bernard - Clinique Victor Hugo | Le Mans | France |
| Hôpital privé du Confluent | Nantes | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France |
| Centre Hospitalier Universitaire Institut Gustave Roussy | Villejuif | France |
| Hospital Universitai Germans Trias i Pujol | Badalona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Complejo Hospitalario de Salamanca | Salamanca | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Spain |
| FG001 | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. |
| FG002 | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| FG003 | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| COMPLETED |
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| NOT COMPLETED |
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Participants included in the Safety Analysis Set were included in the Baseline Characteristics. The Safety Analysis Set includes all patients that have received at least 1 dose (or partial dose) of melflufen, dexamethasone, or partner therapy (bortezomib or daratumumab).
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. |
| BG001 | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. |
| BG002 | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| BG003 | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B:
| Only participants included in the DLT Analysis set were included in this analysis. The DLT Analysis Set was defined as all participants in Phase 1 that complete Cycle 1 of therapy or are discontinued due to a DLT event. | Posted | Count of Participants | Participants | Cycle 1: Day 1 to Day 28 |
|
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| Primary | Phase 2: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better. | All participants included in the Safety Analysis Set were included in this analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Response (BR) | BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 hours, Partial Response (PR)= a > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by > 90% or to < 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of > 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable. | All participants included in the Safety Analysis Set were included in this analysis. | Posted | Count of Participants | Participants | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first. | Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
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| Secondary | Time to Response (TTR) | Time from Cycle 1 Day 1 to a response of PR or better. | Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis. | Posted | Median | Full Range | months | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
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| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time in months from date of initiation of therapy to the earlier of confirmed disease progression or death due to any cause. | All participants included in the Safety Analysis Set were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time from the first dose of melflufen to death due to any cause. | Only participants included in the Safety Analysis Set were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Up to 24 months following confirmed disease progression, or initiation of subsequent therapy (a maximum of 198.9 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Clinical Benefit (DOCB) | DOCB was defined as time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause. | All participants included in the Safety Analysis Set with a confirmed MR or better were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP defined as time from first dose to first documented confirmed progression. | All participants in the Safety Analysis Set are included in this analysis. | Posted | Median | 95% Confidence Interval | months | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (≥ Minimal Response) | ≥ Minimal response for participants included sCR, CR, VGPR, PR and MR. | All participants included in the Safety Analysis Set were included in this analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Next Treatment (TTNT) | Defined as time from date of initiation of therapy to start of next line of therapy. | All participants included in the Safety Analysis Set were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Until death or initiation of subsequent therapy (a maximum of 194.3 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered. | Only participants included in the Safety Analysis Set were included in this analysis. | Posted | Count of Participants | Participants | Cycle 1 Day 1 up to a maximum of 198.9 weeks |
|
Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A (Melflufen+Bortezomib+Dex) 30 mg | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. | 4 | 15 | 9 | 15 | 15 | 15 |
| EG001 | A (Melflufen+Bortezomib+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. | 2 | 8 | 5 | 8 | 8 | 8 |
| EG002 | B (Melflufen+Daratumumab+Dex) 30 mg | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). | 3 | 6 | 4 | 6 | 6 | 6 |
| EG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). | 16 | 27 | 11 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Right ventricular hypertrophy | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Erythema migrans | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoprothrombinaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Withdrawal syndrome | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Gastroenteritis clostridal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Periodonitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Gamm-glutamyltransferase decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin fragility | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye oedema | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Scleral haemorrhage | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Eye naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA (24.0) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
On 04 November 2021, the study was terminated early during Phase 2a.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Chief Operating Officer | Oncopeptides AB | +46 8 615 20 40 | trials@oncopeptides.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2020 | Oct 13, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C482580 | L-melphalanyl-p-L-fluorophenylalanine ethyl ester |
| C585069 | melflufen |
| D003907 | Dexamethasone |
| C018038 | dexamethasone acetate |
| D002123 | Calcium Dobesilate |
| D000069286 | Bortezomib |
| C556306 | daratumumab |
| C116560 | darlin protein, Dictyostelium |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone |
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
|
|
| OG001 | Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle. |
| OG002 | Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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| OG002 | B (Melflufen+Daratumumab+Dex) 30 mg | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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| OG002 |
| B (Melflufen+Daratumumab+Dex) 30 mg |
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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| OG002 | B (Melflufen+Daratumumab+Dex) 30 mg | Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
| OG003 | B (Melflufen+Daratumumab+Dex) 40 mg | Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age). |
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