Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma
NCT ID: NCT06182774
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
570 participants
INTERVENTIONAL
2024-04-10
2032-07-31
Brief Summary
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Detailed Description
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Those that decide to take part in this study, will be randomly placed in one of two groups. If in the usual care group, patients will continue all the myeloma medicines currently being taken. If in the experimental group, patients will stop the daratumumab or isatuximab injection, and continue taking the myeloma tablets currently being taken. Regardless of which group, patients will stay on treatment indefinitely as long they are benefiting from it.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide & Dexamethasone
Lenalidomide
Dose determined at enrollment
Dexamethasone
Dose determined at enrollment
Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
Standard of Care
Daratumumab
Dose determined at enrollment
Lenalidomide
Dose determined at enrollment
Dexamethasone
Dose determined at enrollment
Isatuximab
Dose determined at enrollment
Interventions
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Daratumumab
Dose determined at enrollment
Lenalidomide
Dose determined at enrollment
Dexamethasone
Dose determined at enrollment
Isatuximab
Dose determined at enrollment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Myeloma Canada
UNKNOWN
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Hira Mian
Role: STUDY_CHAIR
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario Canada
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Erma Gardner
Role: primary
Christopher Venner
Role: primary
Rami R. Kotb
Role: primary
Nizar Abdel-Samad
Role: primary
Anthony J. Reiman
Role: primary
Debra Bergstrom
Role: primary
Rouslan Kotchetkov
Role: primary
Shyam Ravisankar
Role: primary
Hira Mian
Role: primary
Bethany Monteith
Role: primary
Armela Dicu
Role: primary
Martha Louzada
Role: primary
Peter James Anglin
Role: primary
Ariah Joshua Schattner
Role: primary
Arleigh B. Robertson McCurdy
Role: primary
Danny Hill
Role: primary
Huma Qawi
Role: primary
Martina Trinkaus
Role: primary
Christie Kim
Role: primary
Sindu Mary Kanjeekal
Role: primary
Richard LeBlanc
Role: primary
Rayan Kaedbey
Role: primary
Michael Sebag
Role: primary
Julie Cote
Role: primary
Ibraheem Mohammed Othman
Role: primary
Julie Stakiw
Role: primary
Other Identifiers
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MY13
Identifier Type: -
Identifier Source: org_study_id
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