Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

  • STATUS
    Recruiting
  • End date
    Oct 10, 2027
  • participants needed
    66
  • sponsor
    Sanofi
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Updated on 19 June 2022
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Summary

Primary Objectives:

  • Part 1 (dose finding, experimental substudies):

-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, 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.

Description

Approximately 28 months

Details
Condition Plasma Cell Myeloma Refractory
Treatment Pomalidomide, Dexamethasone, isatuximab SAR650984, SAR439459, Belantamab mafodotin
Clinical Study IdentifierNCT04643002
SponsorSanofi
Last Modified on19 June 2022

Eligibility

 Yes No Not Sure

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 01-03
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. "Refractory" is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy

Exclusion Criteria

Uncontrolled infection within 14 days prior to randomization
Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma
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)
Uncontrolled or active hepatitis B virus (HBV) infection
Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A
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
Participants with a contraindication to treatment
Any anti-MM drug treatment within 14 days before randomization, including dexamethasone
Vaccination with a live vaccine 4 weeks before the start of the study
Hemoglobin <8 g/dL
Creatinine clearance <30 mL/min
Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN
Patients with grade 3 or 4 hypercalcemia
Substudy 01
Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide
Substudy 03
Current corneal epithelial disease except mild punctate keratopathy
Patients who have received prior therapy with belantamab mafodotin
Platelets <50 × 109/L
Absolute neutrophil count <1.5 × 109/L
Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN
For the first 10 participants: Body weight ≤70 kg
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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