A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/14/2019 |
Start Date: | July 7, 2016 |
End Date: | July 8, 2019 |
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)
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.
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.
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
We found this trial at
13
sites
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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