Multiple Myeloma Clinical Trial

Isatuximab in Combination With Novel Agents in RRMM – Master Protocol

Summary

Primary Objectives:

Part 1 (dose finding, experimental substudies):

-To determine or confirm the recommended dose of novel agents when combined with treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >isatuximab with or without dexamethasone in participants with RRMM.

Part 2 (expansion, 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

Secondary Objectives:

-Master Protocol and Substudy 1-ACT16482-01 (Control Arm):
To assess the overall response rate (ORR) in each treatment arm.
To assess the clinical benefit rate (CBR) in each treatment arm.
To assess the duration of response (DOR) in each treatment arm.
To assess the time to first response (TT1R) in each treatment arm.
To assess the time to best response (TTBR) in each treatment arm.
To assess safety and tolerability in each treatment arm.
To assess progression free survival (PFS) in each treatment arm.
To assess overall survival (OS) in each treatment arm.
To evaluate the potential immunogenicity of isatuximab and novel agents when applicable.
To characterize the PK of isatuximab and novel agents.
To assess disease and treatment related symptoms, cancer and disease specific health-related quality of life, global impact of side effects and confirm/establish clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores.
-Substudy 3-ACT16482-03:
To assess patient-reported visual functioning.

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Full Description

Approximately 28 months

View Eligibility Criteria

Eligibility Criteria

Inclusion 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 3 prior lines of therapy for MM, including PIs and IMiDs or at least 2 prior lines if at least one of these lines consisted of 2 or more multiagent regimens (eg, Induction regimen with autologous stem cell transplant followed by maintenance).
RRMM with measurable disease:

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 <0.26 or >1.65).
Men or woman or childbearing potential should agree to use contraception.

Substudy 01 and 03: Anti-CD38 therapy naive or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. "Refractory" is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy.

Exclusion Criteria:

Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
Uncontrolled infection within 14 days prior to randomization.
Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to randomization, 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 randomization: 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 randomization.
Any anti-MM drug treatment within 14 days before randomization, including dexamethasone.
Participants with a contraindication to treatment.
Vaccination with a live vaccine 4 weeks before the start of the study.
Hemoglobin <8 gdL.
Platelets <50 x 10^9L.
Absolute neutrophil count <1.5 x 10^9/L.
Creatinine clearance <30 mLmin.
Total bilirubin >1.5 x ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 x ULN.
Aspartate aminotransferase and/or alanine aminotransferase >3 x ULN.
Patients with grade 3 or 4 hypercalcemia.

Substudy 01:

Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide.
For the first 10 participants: Body weight ≤70 kg

Substudy 03:

Current corneal epithelial disease except mild punctate keratopathy
Patients who have received prior therapy with belantamab mafodotin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04643002

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 20 Locations for this study

See Locations Near You

University of Illinois-Site Number:8400007
Chicago Illinois, 60612, United States
University of Michigan-Site Number:8400004
Ann Arbor Michigan, 48109, United States
Roswell Park Cancer Institute-Site Number:8400008
Buffalo New York, 14263, United States
Investigational Site Number :0360006
Wollongong New South Wales, 2500, Australia
Investigational Site Number :0360002
Fitzroy Victoria, 3065, Australia
Investigational Site Number :0360003
Heidelberg West Victoria, 3081, Australia
Investigational Site Number :0360005
Melbourne Victoria, 3004, Australia
Investigational Site Number :0360001
Richmond Victoria, 3121, Australia
Investigational Site Number :2500002
Lille , 59037, France
Investigational Site Number :2500001
Nantes , 44093, France
Investigational Site Number :2500003
Paris , 75013, France
Investigational Site Number :2500004
Paris , 75015, France
Investigational Site Number :3000002
Athens , 10676, Greece
Investigational Site Number :3000001
Athens , 11528, Greece
Investigational Site Number :3800001
Meldola Forlì-Cesena, 47014, Italy
Investigational Site Number :3800002
Bologna , 40138, Italy
Investigational Site Number :5780001
Oslo , 0450, Norway
Investigational Site Number :6200001
Coimbra , 3000-, Portugal
Investigational Site Number :6200002
Vila Nova Gaia , 4434-, Portugal
Puerto Rico Medical Research Center, LLC-Site Number:8400005
Hato Rey , 00917, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04643002

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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