NCT04643002 : Phase 1-2 Trial Evaluating Anti-TGFβ Agent (SAR439459) or Pomalidomide in Combination With Isatuximab and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I/II trial has been designed to find the recommended dose of a targeted therapy drug and determine whether it is more effective than chemotherapy as treatment for multiple myeloma.
 

This trial is treating patients with multiple myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Phase 1-2 Trial Evaluating Anti-TGFβ Agent (SAR439459) or Pomalidomide in Combination With Isatuximab and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM)

Commercial Sponsor

Sanofi Aventis

Summary

Eligible patients will be randomised to receive isatuximab and dexamethasone, in addition to either SAR439459 (experimental arm) or pomalidomide (control arm). This trial will include a screening period of up to 28 days for participants treated in each arm. Patients will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor, whichever occurs first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression. For patients who discontinue study treatment with confirmed disease progression, follow-up visits will be done every 3 months (12 weeks) from the date of last IMP administration until death or final cutoff date, whichever comes first. Adverse events and survival status will be collected.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Epworth Hospital Haematology
East Melbourne
Dr Connie Barlas
connie.barlas@epworth.org.au
03 9516 2374

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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