A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma (FUSIONMM-003)
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| ClinicalTrials.gov Identifier: NCT02807454 |
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Recruitment Status :
Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : April 7, 2020
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Daratumumab Drug: Durvalumab Drug: Pomalidomide Drug: Dexamethasone | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | July 7, 2016 |
| Estimated Primary Completion Date : | April 5, 2021 |
| Estimated Study Completion Date : | April 5, 2021 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
Experimental: Daratumumab Plus Durvalumab Treatment
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Drug: Daratumumab Drug: Durvalumab |
Experimental: Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment
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Drug: Daratumumab Drug: Durvalumab Drug: Pomalidomide Drug: Dexamethasone |
Primary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 1.5 years ]Defined as tumor response (including progressive disease), based on the investigator assessments according to the International Myeloma Working Group (IMWG) Uniform Response Criteria
- Adverse Events (AEs) [ Time Frame: Up to approximately 1.5 years ]Number of participants with adverse events
Secondary Outcome Measures :
- Time to response (TTR) [ Time Frame: up to approximately 1.5 years ]Time from enrollment to the first documentation of response (Partial Response [PR] or greater)
- Duration of Response (DOR) [ Time Frame: up to approximately 2.5 years ]Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
- Progression-free Survival (PFS) [ Time Frame: up to approximately 2 years ]Time from enrollment to the first documentation of PD or death from any cause during study, whichever occurs earlier
- Pharmacokinetics- Cmax [ Time Frame: up to approximately 2 years ]Maximum observed concentration
- Pharmacokinetics- AUC [ Time Frame: up to approximately 2 years ]Area under the concentration-time curve
- Pharmacokinetics- Tmax [ Time Frame: up to approximately 2 years ]Time to maximum concentration
- Pharmacokinetics- t1/2 [ Time Frame: up to approximately 2 years ]Terminal elimination half-life
- Pharmacokinetics- CL/F [ Time Frame: up to approximately 2 years ]Apparent total body clearance
- Pharmacokinetics- Vz/F [ Time Frame: up to approximately 2 years ]Apparent volume of distribution
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807454
Locations
Show 43 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Lars Sternas, MD, PhD | Celgene Corporation | |
| Study Director: | Teresa Peluso, MBBS, DCPSA | Celgene |
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT02807454 |
| Other Study ID Numbers: |
MEDI4736-MM-003 |
| First Posted: | June 21, 2016 Key Record Dates |
| Last Update Posted: | April 7, 2020 |
| Last Verified: | April 2020 |
Keywords provided by Celgene:
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Phase 2 Open-Label Durvalumab Daratumumab |
Multiple Myeloma Relapsed and Refractory (RRMM) FUSION MM-003 PD-L1 |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Durvalumab Pomalidomide Daratumumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Immunological |