Recruiting
Phase 3

Daratumumab vs. Daratumumab

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06182774

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daratumumab

Lenalidomide

Dexamethasone

Isatuximab

Study Details

Brief 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?

Conditions

Multiple Myeloma

Study ID

NCT06182774

Start date

Apr 10, 2024

Status verified date

Jan, 2026

Completion date

Jul 31, 2032

Anticipated

Primary completion date

Jan 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with newly diagnosed multiple myeloma that are transplant-ineligible
  • Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g/L; Urine M-protein ≥ 200 mg/24 hours; Involved serum free light chain measurement ≥ 100 mg/L, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin ≥ 750 mg/dL
  • Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.
  • Obtained at least a partial response per the standard 2016 IMWG criteria
  • ECOG performance status 0-3
  • Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in English, French, or a provided validated language.
  • Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
  • Participants must be accessible for treatment and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.
  • Participants of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria:

  • Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.
  • Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial
  • Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.
  • Known human immunodeficiency virus (HIV) with CD4 count < 350 cells/microliter. Note that patients who are HIV positive are eligible, provided:

  • They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND
  • HIV viral load must be < 400 copies/ml within 16 weeks prior to enrollment AND
  • No history of opportunistic infections within the past year.

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lenalidomide & Dexamethasone

active comparator: Daratumumab, Lenalidomide, Dexamethasone & Isatuximab

Standard of Care

Interventions

Daratumumab

Dose determined at enrollment

Lenalidomide

Dose determined at enrollment

Dexamethasone

Dose determined at enrollment

Isatuximab

Dose determined at enrollment

Primary outcome measure

  • Progression-Free Survival [ Time Frame: 9.1 years ]

Central Contacts and Locations

Central contacts

Annette Hay

613-533-6430ahay@ctg.queensu.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

BCCA - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Erma Gardner

250 712-3900

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Rami R. Kotb

204 787-2108

The Moncton Hospital

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

Contacts

Nizar Abdel-Samad

506 870-2404

Regional Health Authority B, Zone 2

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Contacts

Anthony J. Reiman

506 648-6884

Dr. H. Bliss Murphy Cancer Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Debra Bergstrom

709 777-7557

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

William Osler Health System

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Savannah Norman

416 494-2120

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Hira Mian

905 387-9495

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Waterloo Regional Health Network (WRHN)

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Armela Dicu

519 749-4370

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Martha Louzada

519 685-2391

Stronach Regional Health Centre at Southlake

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Peter James Anglin

905 895-4521

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Ariah Joshua Schattner

905 576-8711

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Arleigh B. Robertson McCurdy

613 737-7700

Algoma District Cancer Program

Recruiting

Sault Ste. Marie, Ontario, Canada, P6B 0A8

Contacts

Danny Hill

705 759-3434

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Contacts

Huma Qawi

905 684-7271

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Martina Trinkaus

416 864-5632

St. Joseph's Health Centre

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Windsor Regional Cancer Centre

Recruiting

Windsor, Ontario, Canada, N8W 2X3

Contacts

Sindu Mary Kanjeekal

519 253-5253

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

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Richard LeBlanc

514 252-3400

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Rayan Kaedbey

614 340-8222

St. Mary's Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1M5

Contacts

Tanya Skamene

514 340-8222

The Research Institute of the McGill University

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Michael Sebag

514 398-8307

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

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Julie Cote

418 525-4444

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Ibraheem Mohammed Othman

306 766-2691

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Julie Stakiw

306 655-2980

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jul 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-07-14.