Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05405166 : A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase III study is evaluating different methods of administered targeted therapy (isatuximab) when given in additional to combination therapy (pomalidomide and dexamethasone) in people with relapsed or refractory multiple myeloma who have had previous treatment.
 

This trial is treating patients with relapsed or refractory 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 have had treatment, but your cancer has come back.

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.

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 Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Commercial Sponsor

Sanofi

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive isatuximab administered via subcutaneous injection weekly for 4 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of subsequent cycles. In the Active Comparator Arm, participants will receive isatuximab administered via intravenous infusion weekly for 3 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of each subsequent cycle. Each cycle will be 28 days in duration. All participants will also receive pomalidomide, to be taken orally on Day 1 to Day 21 of each cycle at the time that is is most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day, as well as dexamethasone to betaken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

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.

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