RecruitingPhase 3NCT06182774

Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

Sponsor

Canadian Cancer Trials Group

Enrollment

570 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two strategies for using daratumumab — a widely-used multiple myeloma drug — in older adults who are not candidates for a stem cell transplant: taking it for a fixed period of time and then stopping versus continuing it indefinitely. The goal is to see whether fixed-duration treatment is as effective but easier to tolerate in this population. **You may be eligible if...** - You have newly diagnosed multiple myeloma - You are not eligible for a stem cell transplant - Your myeloma is measurable by blood, urine, or bone marrow tests - You are in good enough health to receive daratumumab-based therapy **You may NOT be eligible if...** - You have already received treatment for your multiple myeloma - You are eligible for a stem cell transplant - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Dose determined at enrollment

DRUGLenalidomide

Dose determined at enrollment

DRUGDexamethasone

Dose determined at enrollment

DRUGIsatuximab

Dose determined at enrollment

Locations(28)

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Kelowna

Kelowna, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Regional Health Authority B, Zone 2

Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

William Osler Health System

Brampton, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, Canada

London Health Sciences Centre Research Inc.

London, Ontario, Canada

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

Niagara Health System

St. Catharines, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CIUSSS de l'Est-de-I'lle-de-Montreal

Montreal, Quebec, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

St. Mary's Hospital

Montreal, Quebec, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

Québec, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT06182774

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