BridgeMD
Isatuximab in combination with novel agents in RRMM – Master protocol and control arm
EU CTIS ID: 2024-514988-25-00
What this study is testing
Master Protocol and Substudy 01: Part 1 (dose finding, experimental substudies) (Master only): -To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM. Part 2 (expansion, controlled experimental substudies): -To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of rate of very good partial response (VGPR) or better. Part 2 (expansion, independent experimental substudies): -To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of overall response rate (ORR).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 regimen with autologous stem cell transplant followed by maintenance is considered one line).
- RRMM with measurable disease: -Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- RRMM with measurable disease:-Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- RRMM with measurable disease:-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 <0.26 or >1.65).
You likely can't join if
- Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
- 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.
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 considered one line).
- RRMM with measurable disease: -Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- RRMM with measurable disease:-Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- RRMM with measurable disease:-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 <0.26 or >1.65).
- Men or woman or childbearing potential should agree to use contraception.
- Substudy 01: 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.
- Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
- 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.
- Patients with grade 3 or 4 hypercalcemia.
- Uncontrolled infection within 14 days prior to first study intervention administration.
- Substudy 01:Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide.
- 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 graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction <40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0).
- 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 administration.
- Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Korea, Republic of
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Korea, Republic of; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.