Study on Isatuximab Combined with New Treatments for Relapsed or Refractory Multiple Myeloma

Sponsor: Sanofi

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04643002

Provider View

This clinical trial is exploring the use of isatuximab, a medication, in combination with new treatments, with or without dexamethasone, for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test how well isatuximab works when combined with new treatments for patients with multiple myeloma that has come back or is not responding to treatment. The study includes several smaller studies, each testing different combinations of treatments. Some of these smaller studies are controlled, meaning they compare the new treatment to a standard treatment, while others are independent and focus solely on the new treatment.

Description

Participants in this study will continue receiving the study treatment until their disease worsens, they experience unacceptable side effects, they choose to stop, the doctor decides to stop, or the study ends, which could be up to about 28 months.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have relapsed or refractory multiple myeloma (RRMM) and have received at least two previous treatments, including specific types of drugs.
  • Have measurable disease based on specific protein levels in blood or urine tests.
  • Agree to use contraception if of childbearing potential.
  • For certain substudies, must not have had recent exposure to anti-CD38 therapy or must have had a break from such therapy for a specified time.
  • For other substudies, must have had previous exposure to anti-CD38 and possibly anti-BCMA therapies.

Exclusion Criteria

  • Have certain other blood disorders or types of myeloma.
  • Have an uncontrolled infection within 14 days before starting the study.
  • Have significant heart or blood vessel problems within the last 3 months.
  • Have certain viral infections like HIV or active hepatitis.
  • Have certain digestive system issues or other cancers unless treated successfully over 3 years ago.
  • Have had any anti-myeloma treatment within 14 days before starting the study.
  • Have low blood counts or poor kidney or liver function.
  • Have received a live vaccine within 4 weeks before the study.

Substudy 01:

  • Have conditions affecting the absorption of certain medications.

Substudy 02:

  • Have a history of certain skin cancers or other local tumors.
  • Have taken certain blood-thinning medications recently.

Substudy 03:

  • Have certain eye conditions.
  • Have received specific prior therapies.

Substudy 04:

  • Have central nervous system disease or a history of seizures.
  • Are taking certain medications that cannot be closely monitored.
  • Have active autoimmune diseases requiring treatment in the past 2 years.

Substudy 05:

  • Cannot swallow tablets.

Substudy 06:

  • Have a history of active autoimmune disorders or certain blood conditions.
  • Have active graft versus host disease or certain viral infections.
  • Have received certain prior therapies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.