Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

  • STATUS
    Recruiting
  • End date
    Jun 7, 2028
  • participants needed
    72
  • sponsor
    Sanofi
Updated on 21 October 2022

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 on21 October 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 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

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
Uncontrolled or active hepatitis B virus (HBV) infection
Active hepatitis C virus (HCV) infection
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
Participants with a contraindication to treatment
York Heart Association Classes III and IV, stroke, transient ischemic attack
Vaccination with a live vaccine 4 weeks before the start of the study
pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or
Hemoglobin <8 g/dL
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
Creatinine clearance <30 mL/min
A
Patients with grade 3 or 4 hypercalcemia
Any of the following within 3 months prior to randomization: treatment resistant
Substudy 01
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
Substudy 03
Platelets <50 x 10^9/L
Current corneal epithelial disease except mild punctate keratopathy
Absolute neutrophil count <1.5 x 10^9/L
Patients who have received prior therapy with belantamab mafodotin
The above information is not intended to contain all considerations relevant to a patient's
Total bilirubin >1.5 x ULN, except for known Gilbert syndrome in which direct
potential participation in a clinical trial
bilirubin should be ≤2.5 x ULN
Aspartate aminotransferase and/or alanine aminotransferase >3 x ULN
Malabsorption syndrome or any condition that can significantly impact the
absorption of pomalidomide
For the first 10 participants: Body weight ≤70 kg
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