Could less be more? major trial tests shorter drug regimen for myeloma
NCT ID NCT06182774
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This study is for older adults with newly diagnosed multiple myeloma who cannot have a stem cell transplant. It compares taking the drugs daratumumab or isatuximab continuously versus stopping after about a year and a half, while continuing other medications. The goal is to see if the shorter treatment works just as well to control the disease and has fewer side effects. About 570 participants will be enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 570 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
29 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Algoma District Cancer Program
RECRUITINGSault Ste. Marie, Ontario, P6B 0A8, Canada
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Allan Blair Cancer Centre
RECRUITINGRegina, Saskatchewan, S4T 7T1, Canada
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BCCA - Kelowna
RECRUITINGKelowna, British Columbia, V1Y 5L3, Canada
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BCCA - Vancouver
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
RECRUITINGQuébec, Quebec, G1J 1Z4, Canada
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CIUSSS de l'Est-de-I'lle-de-Montreal
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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CancerCare Manitoba
RECRUITINGWinnipeg, Manitoba, R3E 0V9, Canada
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Cross Cancer Institute
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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Dr. H. Bliss Murphy Cancer Centre
RECRUITINGSt. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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Kingston Health Sciences Centre
RECRUITINGKingston, Ontario, K7L 2V7, Canada
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Lakeridge Health Oshawa
RECRUITINGOshawa, Ontario, L1G 2B9, Canada
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London Health Sciences Centre Research Inc.
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Niagara Health System
RECRUITINGSt. Catharines, Ontario, L2S 0A9, Canada
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Ottawa Hospital Research Institute
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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Regional Health Authority B, Zone 2
RECRUITINGSaint John, New Brunswick, E2L 4L2, Canada
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Royal Victoria Regional Health Centre
RECRUITINGBarrie, Ontario, L4M 6M2, Canada
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Saskatoon Cancer Centre
RECRUITINGSaskatoon, Saskatchewan, S7N 4H4, Canada
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St. Joseph's Health Centre
RECRUITINGToronto, Ontario, M6R 1B5, Canada
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St. Mary's Hospital
RECRUITINGMontreal, Quebec, H3T 1M5, Canada
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St. Michael's Hospital
RECRUITINGToronto, Ontario, M5B 1W8, Canada
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Stronach Regional Health Centre at Southlake
RECRUITINGNewmarket, Ontario, L3Y 2P9, Canada
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The Jewish General Hospital
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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The Moncton Hospital
RECRUITINGMoncton, New Brunswick, E1C 6Z8, Canada
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The Research Institute of the McGill University
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Thunder Bay Regional Health Sciences Centre/
RECRUITINGThunder Bay, Ontario, P7B 6V4, Canada
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Waterloo Regional Health Network (WRHN)
RECRUITINGKitchener, Ontario, N2G 1G3, Canada
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William Osler Health System
RECRUITINGBrampton, Ontario, L6R 3J7, Canada
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Windsor Regional Cancer Centre
RECRUITINGWindsor, Ontario, N8W 2X3, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?