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.

CARTITUDE-5 : A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

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 | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This Phase III study is comparing how effective VRd induction (bortezomib, lenalidomide and dexamethasone) therapy when it is followed by either immunotherapy (cilta-cel) or a combination of lenalidomide and dexamethasone in people with newly diagnosed 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 are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

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

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

Scientific Title

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Commercial Sponsor

Janssen Research & Development, LLC

Summary

This is a randomised trial with two experimental arms for people newly diagnosed multiple myeloma for whom ASCT is not planned as initial terapy. All participants will receive bortezomib (administered subcutaneously), lenalidomide (administered orally), and dexamethasone (administered orally) (VRd) regimen for 6 cycles before randomisation. In Experimental Arm A, participants will receive VRd+Rd (Standard Therapy). Following randomisation, these participants will receive 2 more cycles of VRd. Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity. In Experimental Arm B, participants will receive VRd+Clitacabtagene Autoleucel (Cita-cel). Following randomisation, these participants will undergo apheresis and receive two more cycles of VRd as bridging therapy. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen of cyclophosphamide (administered intravenously) and fludarabine (administered intravenously) and Cilta-cel infusion.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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