A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma (FUSIONMM-003)
Multiple Myeloma
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
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
Experimental
Experimental
Daratumumab Plus Durvalumab Treatment
Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment
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