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RECRUITING
NCT06182774
PHASE3

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

Sponsor: Canadian Cancer Trials Group

View on ClinicalTrials.gov

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?

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2024-04-10

Completion Date

2032-07-31

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Daratumumab

Dose determined at enrollment

DRUG

Lenalidomide

Dose determined at enrollment

DRUG

Dexamethasone

Dose determined at enrollment

DRUG

Isatuximab

Dose determined at enrollment

Locations (26)

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

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