Actively Recruiting
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
Led by Sanofi · Updated on 2026-03-30
258
Participants Needed
28
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.
CONDITIONS
Official Title
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age inclusive or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy for multiple myeloma, including proteasome inhibitors and immunomodulatory drugs.
- Relapsed or refractory multiple myeloma with measurable disease defined by serum M protein ≥0.5 g/dL, urine M protein ≥200 mg/24 hours, or serum free light chain criteria.
- Men or women of childbearing potential must agree to use contraception.
- For Substudies 01 and 06: Anti-CD38 therapy naive or prior exposure with at least 12 months washout after last dose.
- For Substudies 02 and 03: Anti-CD38 therapy naive or prior exposure without refractory disease and at least 6 months washout.
- For Substudy 04: Prior exposure to anti-CD38 and anti-BCMA therapy with at least 2 cycles each.
- For Substudy 05: Prior exposure to anti-CD38 therapy with at least 2 cycles and mandatory prior exposure to BCMA targeted therapy if available.
You will not qualify if you...
- Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
- Uncontrolled infection within 14 days prior to first study intervention.
- Significant cardiac or vascular disease within 3 months prior to first study intervention.
- Known AIDS-related illness, HIV requiring treatment, or active hepatitis A.
- Uncontrolled or active hepatitis B or C infection.
- Recent treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease within 3 months.
- Second malignancy except certain skin cancers or in situ carcinoma unless treated curatively more than 3 years ago.
- Anti-multiple myeloma treatment within 14 days before first study intervention.
- Contraindications to treatment or live vaccine within 4 weeks before study start.
- Hemoglobin <8 g/dL, platelets <50x10^9/L, neutrophils <1.0x10^9/L.
- Creatinine clearance <30 mL/min/1.73m2.
- Elevated bilirubin, liver enzymes, or grade 3 or 4 hypercalcemia.
- Substudy-specific exclusions including malabsorption syndrome, prior therapies, corneal disease, CNS disease, autoimmune disorders, inability to swallow tablets, and prior stem cell transplant depending on the substudy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Winship Cancer Institute of Emory University- Site Number : 8400010
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Illinois-Chicago - College of Medicine- Site Number : 8400007
Chicago, Illinois, United States, 60612
Completed
3
University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Roswell Park Cancer Institute- Site Number : 8400008
Buffalo, New York, United States, 14263
Actively Recruiting
5
The Ohio State University- Site Number : 8400012
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Investigational Site Number : 0360006
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
7
Investigational Site Number : 0360002
Melbourne, Victoria, Australia, 3065
Actively Recruiting
8
Investigational Site Number : 0360001
Richmond, Victoria, Australia, 3121
Actively Recruiting
9
Investigational Site Number : 2500003
Paris, Washington, France, 75651
Actively Recruiting
10
Investigational Site Number : 2500002
Lille, France, 59037
Actively Recruiting
11
Investigational Site Number : 2500001
Nantes, France, 44093
Actively Recruiting
12
Investigational Site Number : 2500004
Paris, France, 75015
Actively Recruiting
13
Investigational Site Number : 2760006
Frankfurt, Germany, 60590
Actively Recruiting
14
Investigational Site Number : 2760008
Lübeck, Germany, 23538
Actively Recruiting
15
Investigational Site Number : 3000002
Athens, Greece, 106 76
Actively Recruiting
16
Investigational Site Number : 3000001
Athens, Greece, 115 28
Actively Recruiting
17
Investigational Site Number : 3760002
Jerusalem, Israel, 9112001
Actively Recruiting
18
Investigational Site Number : 3760003
Ramat Gan, Israel, 5262100
Actively Recruiting
19
Investigational Site Number : 3760001
Tel Aviv, Israel, 6423906
Actively Recruiting
20
Investigational Site Number : 3800001
Meldola, Reggio Emilia, Italy, 47014
Actively Recruiting
21
Investigational Site Number : 5780001
Oslo, Norway, 0450
Actively Recruiting
22
Investigational Site Number : 6200001
Coimbra, Portugal, 3000-075
Actively Recruiting
23
Investigational Site Number : 6200002
Porto, Portugal, 4434-502
Actively Recruiting
24
Puerto Rico Medical Research Center- Site Number : 8400005
Hato Rey, Puerto Rico, Puerto Rico, 00917
Actively Recruiting
25
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Actively Recruiting
26
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Actively Recruiting
27
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 06351
Actively Recruiting
28
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea, 06591
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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