Not provided
Not provided
Not provided
Not provided
Health Authority request due to class effect
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3).
On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab Plus Durvalumab Treatment | Experimental |
|
|
| Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. | From first dose to up to approximately 66 months |
| Number of Participants With Adverse Events (AEs) | Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE. | From first dose to 90 days after last dose (up to approximately 58 months) |
| Number of Participants With Serious Adverse Events (SAEs) | Number of participants who experienced at least one serious adverse event. An SAE is any AE occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, constitutes an important medical event. | From first dose to 90 days after last dose (up to approximately 58 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-To-Response (TTR) | Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| UCLA Division of Hematology Oncology |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Participants were randomized in a 1:1 ratio to receive either Durvalumab + Daratumumab (D2) or Durvalumab + Daratumumab + Pomalidomide + Dexamethasone (PD3). 32 participants were treated in the Simon Stage 1: D2 arm. No participants enrolled in the Simon Stage 2: D2 arm. 5 participants treated in the PD3 arm.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Simon Stage 1: D2 Arm | Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Durvalumab |
| Drug |
|
| Pomalidomide | Drug |
|
| Dexamethasone | Drug |
|
| From enrollment to earliest documented response (up to approximately 66 months) |
| Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm | Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months) |
| Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm | Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease progression as determined by the investigator. Participants who are alive or lost to follow-up will be censored on the last-known-to-be-alive date. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. | From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months) |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm | Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months) |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm | Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months) |
| Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | Cycle 1 - Days 2, 8, 15, 22 |
| Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | Cycle 1 - Days 2, 8, 15, 22 |
| Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | Cycle 1 - Days 2, 8, 15, 22 |
| Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | Cycle 1 - Days 2, 8, 15, 22 |
| Los Angeles |
| California |
| 90095-1752 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Local Institution - 007 | Denver | Colorado | 80218 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Dana-Farber Partners Cancer Care, Inc. | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology Nashville Drug Development Unit | Nashville | Tennessee | 37203 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| AZ St-Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Universitaire Ziekenhuizen Leuven Univeristy Hospitals Leuven | Leuven | B-3000 | Belgium |
| Cliniques Universitaires UCL de Mont-Godine | Yvoir | 5530 | Belgium |
| Local Institution - 103 | Saint John | New Brunswick | E2L 3L6 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 3L6 | Canada |
| Local Institution - 104 | Toronto | Ontario | M5G 2M9 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 101 | Montreal | Quebec | H1T 2M4 | Canada |
| MUHC Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Local Institution - 552 | Copenhagen | 2100 | Denmark |
| Rigshospitalet University Hospital | Copenhagen | 2100 | Denmark |
| Local Institution - 553 | Odense | DK-5000 | Denmark |
| Odense University Hospital | Odense | DK-5000 | Denmark |
| Local Institution - 551 | Vejle | 7100 | Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| Universitatsklinikum Carl Gustav Carus an der TU Dresden | Dresden | 01307 | Germany |
| Local Institution - 203 | Heidelberg | 69115 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | 69115 | Germany |
| University Hospital Tubingen | Tübingen | 72076 | Germany |
| Local Institution - 201 | Würzburg | 97080 | Germany |
| Universitatsklinikum Wuerzburg | Würzburg | 97080 | Germany |
| Local Institution - 354 | Bologna | 40138 | Italy |
| Policlinico S. Orsola - Malpighi | Bologna | 40138 | Italy |
| A.O.U. Maggiore della Carità | Novara | 28100 | Italy |
| Local Institution - 353 | Novara | 28100 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Local Institution - 355 | Padova | 35128 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello | Palermo | 90146 | Italy |
| A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia | Pisa | 56126 | Italy |
| Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO | Barcelona | 08907 | Spain |
| Local Institution - 453 | Barcelona | 08907 | Spain |
| Hospital de Cabuenes | Gijón | 33394 | Spain |
| Local Institution - 451 | Gijón | 33394 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Local Institution - 452 | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 60 Gothenburg | Sweden |
| Local Institution - 501 | Lund | 221 85 | Sweden |
| Skanes Universitetssjukhus Malmo | Lund | 221 85 | Sweden |
| Local Institution - 502 | Stockholm | SE-141 86 | Sweden |
| Karolinska Universitetssjukhuset - Huddinge | Stockholm | SE-14186 | Sweden |
| St. Bartholomew's and The Royal London Hospital | London | EC1A 7BE | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Local Institution - 252 | Oxford | 0X3 7LE | United Kingdom |
| Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine | Oxford | 0X3 7LE | United Kingdom |
| Local Institution - 253 | Sutton (Surrey) | SM2 5PT | United Kingdom |
| Royal Marsden Hospital | Sutton (Surrey) | SM2 5PT | United Kingdom |
| The Royal Wolverhampton Hospital NHS Trust | Wolverhampton | WV10 0QP | United Kingdom |
| PD3 Arm |
Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles |
| Participants in the D2 Arm Who Also Received Pomalidomide + Dexamethasone |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Simon Stage 1: D2 Arm | Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2. |
| BG001 | PD3 Arm | Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
|
| 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 | Overall Response Rate (ORR) | Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. | All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. | Posted | Number | Percentage of participants | From first dose to up to approximately 66 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE. | All participants who received at least 1 dose of the study medications. | Posted | Count of Participants | Participants | From first dose to 90 days after last dose (up to approximately 58 months) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants who experienced at least one serious adverse event. An SAE is any AE occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, constitutes an important medical event. | All participants who received at least 1 dose of the study medications. | Posted | Count of Participants | Participants | From first dose to 90 days after last dose (up to approximately 58 months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time-To-Response (TTR) | Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better). | All enrolled participants who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment in the D2, D2 + Pomalidomide + Dexamethasone, and PD3 arms. | Posted | Median | Full Range | Weeks | From enrollment to earliest documented response (up to approximately 66 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm | Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms. | Posted | Median | 95% Confidence Interval | Months | From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm | Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease progression as determined by the investigator. Participants who are alive or lost to follow-up will be censored on the last-known-to-be-alive date. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. | All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in the PD3 arm. | Posted | Median | 80% Confidence Interval | Months | From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm | Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms. | Posted | Median | 95% Confidence Interval | Months | From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm | Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h). | All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in the PD3 arm. | Posted | Median | 80% Confidence Interval | Months | From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. Cmax was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Cycle 1 - Days 2, 8, 15, 22 |
|
| |||||||||||||||||||||||||||||
| Secondary | Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. Tmax was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only. | Posted | Median | Full Range | Hour | Cycle 1 - Days 2, 8, 15, 22 |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. [AUC(0-Last)] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*ug/mL | Cycle 1 - Days 2, 8, 15, 22 |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm | Pharmacokinetics of Durvalumab derived from serum concentration versus time data. | All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. [AUC(TAU)] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*ug/mL | Cycle 1 - Days 2, 8, 15, 22 |
|
|
All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simon Stage 1: D2 Arm | Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2. | 11 | 32 | 17 | 32 | 31 | 32 |
| EG001 | PD3 Arm | Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles | 4 | 5 | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Death | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Corynebacterium infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.1 | Systematic Assessment |
| |
| Conjunctival irritation | Eye disorders | 24.1 | Systematic Assessment |
| |
| Ophthalmic vein thrombosis | Eye disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.1 | Systematic Assessment |
| |
| Chills | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 24.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.1 | Systematic Assessment |
|
This study stopped enrolling participants on 05-Sep-2017 and was terminated earlier than planned on 03-Jan-2022. This results disclosure report provides outputs from the Simon Stage 1: D2 and PD3 arms. Simon Stage 2: D2 did not enroll any participants.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email: | Clinical.Trials@bms.com |
| Jan 3, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C556306 | daratumumab |
| C000613593 | durvalumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| OG002 | PD3 Arm | Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles |
|
|
| OG001 |
| Simon Stage 1: D2 + Pomalidomide + Dexamethasone |
Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|