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A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma (FUSIONMM-003)

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daratumumab
Durvalumab
Pomalidomide
Dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Phase 2, Open-Label, Durvalumab, Daratumumab, Multiple Myeloma, Relapsed and Refractory (RRMM), FUSION MM-003, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have measurable disease as defined by m-protein or serum free light chain.
  • Must have failed last line of treatment (refractory to last line of treatment).
  • Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed)
  • Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Must be at least 18 years of age

Exclusion Criteria:

  • Has non-secretory multiple myeloma
  • Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
  • Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
  • Has received prior treatment with daratumumab or other anti-CD38 therapies previously
  • Has undergone prior organ or allogeneic hematopoetic stem cell transplantation
  • Has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization.
  • Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
  • Has received investigational agents within 28 days or 5 half-lives (whichever is longer) of Study Day 1
  • Has received live, attenuated vaccine within 30 days prior to Study Day 1
  • Has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
  • Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
  • Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
  • Has a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative)
  • Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma
  • Has clinically significant cardiac disease
  • Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study

Sites / Locations

  • City of Hope National Medical Center
  • UCLA Division of Hematology Oncology
  • Colorado Blood Cancer Institute
  • Local Institution - 007
  • Emory University Hospital
  • University of Chicago Medical Center
  • Center For Cancer and Blood Disorders
  • Dana-Farber Partners Cancer Care, Inc.
  • Washington University
  • Hackensack University Medical Center
  • Perelman Center for Advanced Medicine
  • University of Pennsylvania - Perelman Center for Advanced Medicine
  • Sarah Cannon Research Institute
  • Tennessee Oncology Nashville Drug Development Unit
  • Swedish Medical Center
  • AZ St-Jan Brugge Oostende AV
  • Universitaire Ziekenhuizen Leuven Univeristy Hospitals Leuven
  • Cliniques Universitaires UCL de Mont-Godine
  • Local Institution - 103
  • Saint John Regional Hospital
  • Local Institution - 104
  • Princess Margaret Cancer Centre
  • Hopital Maisonneuve-Rosemont
  • Local Institution - 101
  • MUHC Glen Site
  • Local Institution - 552
  • Rigshospitalet University Hospital
  • Local Institution - 553
  • Odense University Hospital
  • Local Institution - 551
  • Vejle Hospital
  • Universitatsklinikum Carl Gustav Carus an der TU Dresden
  • Local Institution - 203
  • Universitatsklinikum Heidelberg
  • University Hospital Tubingen
  • Local Institution - 201
  • Universitatsklinikum Wuerzburg
  • Local Institution - 354
  • Policlinico S. Orsola - Malpighi
  • A.O.U. Maggiore della Carità
  • Local Institution - 353
  • Azienda Ospedaliera di Padova
  • Local Institution - 355
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
  • A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
  • Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
  • Local Institution - 453
  • Hospital de Cabuenes
  • Local Institution - 451
  • Hospital Universitario Fundacion Jimenez Diaz
  • Local Institution - 452
  • Hospital 12 de Octubre
  • Sahlgrenska University Hospital
  • Local Institution - 501
  • Skanes Universitetssjukhus Malmo
  • Local Institution - 502
  • Karolinska Universitetssjukhuset - Huddinge
  • St. Bartholomew's and The Royal London Hospital
  • Christie Hospital
  • Local Institution - 252
  • Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
  • Local Institution - 253
  • Royal Marsden Hospital
  • The Royal Wolverhampton Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Daratumumab Plus Durvalumab Treatment

Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment

Arm Description

Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward

Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward oral POM at 4mg/day on days 1 to 21 oral/IV dex at 40mg/day (>75 years old) or 20mg/day (>75 years old) on days 1, 8, 15 and 22

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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).
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.
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).
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).
Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
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.
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.

Full Information

First Posted
June 17, 2016
Last Updated
February 16, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02807454
Brief Title
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Acronym
FUSIONMM-003
Official Title
A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Health Authority request due to class effect
Study Start Date
July 7, 2016 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
January 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Phase 2, Open-Label, Durvalumab, Daratumumab, Multiple Myeloma, Relapsed and Refractory (RRMM), FUSION MM-003, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daratumumab Plus Durvalumab Treatment
Arm Type
Experimental
Arm Description
Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward
Arm Title
Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment
Arm Type
Experimental
Arm Description
Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward oral POM at 4mg/day on days 1 to 21 oral/IV dex at 40mg/day (>75 years old) or 20mg/day (>75 years old) on days 1, 8, 15 and 22
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
From first dose to up to approximately 66 months
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From first dose to 90 days after last dose (up to approximately 58 months)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
From first dose to 90 days after last dose (up to approximately 58 months)
Secondary Outcome Measure Information:
Title
Time-To-Response (TTR)
Description
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).
Time Frame
From enrollment to earliest documented response (up to approximately 66 months)
Title
Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm
Description
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).
Time Frame
From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)
Title
Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm
Description
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.
Time Frame
From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)
Title
Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm
Description
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).
Time Frame
From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
Title
Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm
Description
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).
Time Frame
From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
Title
Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm
Description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
Time Frame
Cycle 1 - Days 2, 8, 15, 22
Title
Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm
Description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
Time Frame
Cycle 1 - Days 2, 8, 15, 22
Title
Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm
Description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
Time Frame
Cycle 1 - Days 2, 8, 15, 22
Title
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm
Description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
Time Frame
Cycle 1 - Days 2, 8, 15, 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have measurable disease as defined by m-protein or serum free light chain. Must have failed last line of treatment (refractory to last line of treatment). Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed) Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale Must be at least 18 years of age Exclusion Criteria: Has non-secretory multiple myeloma Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1 Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways). Has received prior treatment with daratumumab or other anti-CD38 therapies previously Has undergone prior organ or allogeneic hematopoetic stem cell transplantation Has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization. Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1 Has received investigational agents within 28 days or 5 half-lives (whichever is longer) of Study Day 1 Has received live, attenuated vaccine within 30 days prior to Study Day 1 Has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C Has a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative) Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma Has clinically significant cardiac disease Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA Division of Hematology Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 007
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Center For Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Dana-Farber Partners Cancer Care, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania - Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology Nashville Drug Development Unit
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven Univeristy Hospitals Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godine
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution - 103
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
Local Institution - 104
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 101
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
MUHC Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution - 552
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Rigshospitalet University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution - 553
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Local Institution - 551
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 203
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
University Hospital Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 201
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitatsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 354
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Local Institution - 353
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 355
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution - 453
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de Cabuenes
City
Gijon
ZIP/Postal Code
33394
Country
Spain
Facility Name
Local Institution - 451
City
Gijon
ZIP/Postal Code
33394
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 452
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
60 Gothenburg
Country
Sweden
Facility Name
Local Institution - 501
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Skanes Universitetssjukhus Malmo
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution - 502
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset - Huddinge
City
Stockholm
ZIP/Postal Code
SE-14186
Country
Sweden
Facility Name
St. Bartholomew's and The Royal London Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 252
City
Oxford
ZIP/Postal Code
0X3 7LE
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
City
Oxford
ZIP/Postal Code
0X3 7LE
Country
United Kingdom
Facility Name
Local Institution - 253
City
Sutton (Surrey)
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton (Surrey)
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Wolverhampton Hospital NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

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