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There was a change in the Sponsor's research strategy; safety concerns were not a factor.
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This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romidepsin + Bortezomib | Experimental | Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib was administered at a dose of 1.0 mg/m^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin infusion. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participant Best Overall Response As Assessed by the Investigator | Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. Stable Disease: Less than MR, but not PD Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-emergent Adverse Events (TEAEs) | Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death. |
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Inclusion Criteria
Patients must fulfill all of the following criteria to be eligible for study participation:
Male or female patients aged ≥ 18 years old
Has given voluntary written informed consent before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Previously diagnosed with multiple myeloma (MM) based on standard criteria as follows:
Major criteria:
Minor criteria:
Any of the following sets of criteria will confirm the diagnosis of MM:
Any two of the major criteria
Major criterion 1 plus minor criterion 2, 3, or 4.
Major criterion 3 plus minor criterion 1 or 3.
Minor criteria 1, 2, and 3 or 1, 2, and 4.
Currently has MM with:
o Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of >=1 gm/dL and/or urine monoclonal immunoglobulin spike of >=200 mg/24 hours, or evidence of lytic bone disease
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Life-expectancy > 3 months
All women of childbearing potential must use an effective barrier method of contraception. Male patients should use a barrier method of contraception during the treatment period and for 3 months thereafter
Patients must meet the following laboratory criteria at Baseline (Day 1 of Cycle 1, before study drug administration):
Patients must meet the following laboratory criteria at the Screening visit conducted within 14 days of enrollment (Day 1, Cycle 1):
Exclusion Criteria
Patients are ineligible for entry if any of the following criteria are met:
Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or thalidomide, lenalidomide, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of romidepsin
Prior major surgery within 3 weeks prior to the first day of treatment
Use of any investigational agent within 4 weeks of study entry
Prior therapy with romidepsin
Any known cardiac abnormalities such as:
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
Plasma cell leukemia
Primary amyloidosis
Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
Severe hypercalcemia, i.e., serum calcium ≥14 mg/dL (3.5 mmol/L)
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Other concurrent severe and/or uncontrolled medical or psychiatric conditions.
Concomitant use of drugs that may cause a prolongation of the QTc
Concomitant use of CYP3A4 inhibitors
Patients who have hypersensitivity to bortezomib, boron or mannitol
Patients who are pregnant or breast-feeding
Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff
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| Name | Affiliation | Role |
|---|---|---|
| Tina Neilson | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Cancer Center | Loma Linda | California | 92354 | United States | ||
| Desert Cancer Care, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Berenson J, et al. A phase II study of a 1-hour infusion of romidepsin combined with bortezomib for multiple myeloma (MM) patients with relapsed or refractory disease. Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando FL. Abstract No. e10908. J Clin Oncol 2009;27(15s) |
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Stratum 1 (bortezomib resistant) had 19 participants. Stratum 2 (non-bortezomib resistant) had 13 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Romidepsin + Bortezomib | Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Romidepsin + Bortezomib | Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Count of Participant Best Overall Response As Assessed by the Investigator | Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. Stable Disease: Less than MR, but not PD Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. | Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study. | Posted | up to 8 months |
up to 9 months
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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 | Romidepsin + Bortezomib | Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| C087123 | romidepsin |
| D047630 | Depsipeptides |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
|
| Romidepsin | Drug | Romidepsin initially was administered at a dose of 10 mg/m^2 as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. Based on the occurrence of Grade 3 thrombocytopenia at this dose level, the dose was reduced by protocol amendment to 8 mg/m^2. |
|
|
| up to 9 months |
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples. | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration of Romidepsin | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Time to Maximum Observed Concentration (Tmax) | Time to maximum observed concentration of Romidepsin | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Terminal Half-life (t1/2) | Terminal half-life of Romidepsin | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Total Clearance (CL) | Total clearance of Romidepsin | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Total Volume of Distribution (Vz) | Total volume of distribution of Romidepsin | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
| Kaplan Meier Estimate for Time to Progression Assessed by the Investigator | Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | up to month 8 |
| Kaplan Meier Estimate for Time to Response Assessed by the Investigator | The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response). Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. | up to month 8 |
| Kaplan Meier Estimate for Duration of Response Assessed by the Investigator | Duration of response is defined as the time from first response to progressive disease as assessed by the investigator. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | up to month 8 |
| Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator | Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | up to month 8 |
| Kaplan Meier Estimates for Overall Survival | Overall survival is the time from initiation of therapy to death from any cause. | up to month 8 |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105 | United States |
| James R Berenson, MD, Inc. | West Hollywood | California | 90069 | United States |
| Georgia Cancer Specialists I, PC | Atlanta | Georgia | 30341 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Mecklenburg Medical Group | Charlotte | North Carolina | 28204 | United States |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Dallas Oncology Consultants, P.A. | Duncanville | Texas | 75137 | United States |
| Oncology Consultants, P.A | Houston | Texas | 77024 | United States |
| Central Utah Clinic, PC | Provo | Utah | 84604 | United States |
| Virginia Mason Medical Centre | Seattle | Washington | 98101 | United States |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Romidepsin + Bortezomib | Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. |
|
| Secondary | Participants With Treatment-emergent Adverse Events (TEAEs) | Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death. | Safety population of participants who took at least one dose of drug. | Posted | Number | participants | up to 9 months |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples. | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) | Maximum observed concentration of Romidepsin | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) | Time to maximum observed concentration of Romidepsin | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Median | Full Range | hr | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Terminal Half-life (t1/2) | Terminal half-life of Romidepsin | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Total Clearance (CL) | Total clearance of Romidepsin | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Total Volume of Distribution (Vz) | Total volume of distribution of Romidepsin | A subset of participants from the lead investigator's site had PK samples taken. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion |
|
|
|
| Secondary | Kaplan Meier Estimate for Time to Progression Assessed by the Investigator | Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | Intent to treat population. Analysis was not performed due to early termination of the study. | Posted | up to month 8 |
|
|
| Secondary | Kaplan Meier Estimate for Time to Response Assessed by the Investigator | The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response). Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. | Intent to treat population. However efficacy data was not analyzed due to the early termination of the study. | Posted | up to month 8 |
|
|
| Secondary | Kaplan Meier Estimate for Duration of Response Assessed by the Investigator | Duration of response is defined as the time from first response to progressive disease as assessed by the investigator. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | Intent to treat population. However efficacy data was not analyzed due to the early termination of the study. | Posted | up to month 8 |
|
|
| Secondary | Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator | Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first. Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia. | Intent to treat population. However efficacy data was not analyzed due to the early termination of the study. | Posted | up to month 8 |
|
|
| Secondary | Kaplan Meier Estimates for Overall Survival | Overall survival is the time from initiation of therapy to death from any cause. | Intent to treat population. However efficacy data was not analyzed due to the early termination of the study. | Posted | up to month 8 |
|
|
| 14 |
| 32 |
| 32 |
| 32 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Electrocardiogram QT prolongation | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation
| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| At least 1 Bortezomib-related TEAE |
|
| At least 1 >=Grade 3 TEAE |
|
| At least 1 Grade 4 TEAE |
|
| At least 1 serious TEAE |
|
| At least 1 TEAE leading to discontinuation |
|
| At least 1 TEAE leading to death |
|