Clinical trial for Plasma Cell Myeloma Refractory
Official title Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
ClinicalTrials.gov ID: NCT04643002
What this study is testing
What is Isatuximab?
An investigational intravenous monoclonal antibody being studied as a potential treatment for relapsed or refractory plasma cell myeloma. Isatuximab is designed to bind to the CD38 protein on myeloma cells and help the immune system destroy them.
Also referred to as SAR650984, Sarclisa®.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding isatuximab to new drugs helps people with relapsed or refractory myeloma.
- Who it's for
- You may be able to join if you have plasma cell myeloma that has returned or did not respond to earlier treatments.
- What's involved
- You would receive isatuximab together with other new medicines, sometimes with a steroid. You will have regular visits for blood tests and health checks.
- Time commitment
- The study lasts several months, with visits every few weeks for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be 18 years of age inclusive or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction...
- Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
You likely can't join if
- 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 administration.
- Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg...
- Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active...
- Uncontrolled or active hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV) infection.
See the full eligibility criteria
- Participant must be 18 years of age inclusive or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is...
- Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio \ 1.65).
- Men or woman or childbearing potential should agree to use contraception.
- Substudy 01, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dose. "Exposure" is defined as at least 2 cycles of therapy.
- Substudies 02, 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose.
- Substudy 04: Anti-CD38 and anti-B cell maturation antigen (BCMA) therapy (if available) prior exposed participants with RRMM. For anti-CD38, "Exposure" is defined as at least 2 cycles of therapy.
- Substudy 05: Participants with RRMM with at least 2 cycles of prior exposure to anti-CD38 therapy.
- 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 administration.
- Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass...
- Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A.
- Uncontrolled or active hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV) infection.
- Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease.
- Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention...
- Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.
- Participants with a contraindication to treatment.
- Vaccination with a live vaccine 4 weeks before the start of the study.
- Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Hemoglobin \<8 g/dL.
- Platelets \<50 × 10\^9/L.
- Absolute neutrophil count \<1.0 × 10\^9/L.
- Creatinine clearance \<30 mL/min/1.73m2.
- Total bilirubin \>1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN.
- Aspartate aminotransferase and/or alanine aminotransferase \>3 × ULN.
- History of resected/ablated basal or squamous cell carcinoma (SCC) of the skin or carcinoma in situ of the cervix, or other local tumors, even if considered cured by local treatment.
- Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior to the first dose of SAR439459.
- Current corneal epithelial disease except mild punctate keratopathy.
- Central nervous system or leptomeningeal disease.
- Medical history of seizure.
- Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg, digoxin, warfarin) if cannot be closely monitored.
- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), except controlled by...
- History of active autoimmune disorders.
- History of autoimmune hemolytic anemia or autoimmune. thrombocytopenia.
- Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
- Prior allogenic hematopoietic stem cell transplant (allo-HSCT).
- Patient with chronic active EBV infection.
- Patients with known history of HLH.
- Hemoglobin \< 9 g/dL.
- Prior therapy with any anti-CD47 or anti signal regulatory protein alpha agent. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Buffalo, New York, United States
- Columbus, Ohio, United States
- Wollongong, New South Wales, Australia
- Melbourne, Victoria, Australia
- Richmond, Victoria, Australia
- Lille, France
- Nantes, France
- Paris, France
- Frankfurt, Germany
- Lübeck, Germany
- Athens, Greece
- Jerusalem, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Meldola, Reggio Emilia, Italy
- Oslo, Norway
- Seoul, Seoul-teukbyeolsi, South Korea
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; Buffalo, New York, United States; Columbus, Ohio, United States; Wollongong, New South Wales, Australia; Melbourne, Victoria, Australia and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.