NCT04045795 : A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is testing two different ways to give an immunotherapy drug (isatuximab) to patients with Multiple Myeloma, who have gotten worse or not responded to prior treatment.
 

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 been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Commercial Sponsor

Sanofi Aventis

Summary

Eligible patients will be randomised to receive isatuximab intravenously or subcutaneously, in combination with pomalidomide and dexamethasone for the treatment of relapsed/refractory Multiple Myeloma. The primary objective of the trial will be to evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV). Study duration will be variable, depending on treatment and follow up periods, including 21 days of screening. Treatment will be administered until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of isatuximab, or approximately 14 months after the first study treatment.

Recruiting Hospitals Read MoreRead more

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.

Next