Stopping or Continuing Anti-CD38 Antibody Treatment in Older Adults With Myeloma
Tests stopping anti-CD38 antibody treatment after a set time in older myeloma patients.
Plain-language title generated from the registry record
Registry title: Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
Key facts
- Where
- Barrie, Brampton, Edmonton, Hamilton, Kelowna, Kingston, Kitchener, London, Mississauga, Moncton, Montreal, Newmarket, Oakville, Oshawa, Ottawa, Québec, Regina, Saint John, Saskatoon, Sault Ste. Marie, St. Catharines, St. John's, Thunder Bay, Toronto, Vancouver, Windsor, and Winnipeg, CanadaSee the 31 sites
- Phase
- Phase 3
Where in Canada
- Royal Victoria Regional Health CentreBarrie, CanadaTaking people
- William Osler Health SystemBrampton, CanadaTaking people
- Cross Cancer InstituteEdmonton, CanadaTaking people
- Juravinski Cancer Centre at Hamilton Health SciencesHamilton, CanadaTaking people
- BCCA - KelownaKelowna, CanadaTaking people
- Kingston Health Sciences CentreKingston, CanadaTaking people
- Waterloo Regional Health Network (WRHN)Kitchener, CanadaTaking people
- London Health Sciences Centre Research Inc.London, CanadaTaking people
- Trillium Health Partners - Credit Valley HospitalMississauga, CanadaTaking people
- The Moncton HospitalMoncton, CanadaTaking people
- CIUSSS de l'Est-de-I'lle-de-MontrealMontreal, CanadaTaking people
- St. Mary's HospitalMontreal, CanadaTaking people
- The Jewish General HospitalMontreal, CanadaTaking people
- The Research Institute of the McGill UniversityMontreal, CanadaTaking people
- Stronach Regional Health Centre at SouthlakeNewmarket, CanadaTaking people
- Oakville Trafalgar Memorial HospitalOakville, CanadaTaking people
- Lakeridge Health OshawaOshawa, CanadaTaking people
- Ottawa Hospital Research InstituteOttawa, CanadaTaking people
- CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)Québec, CanadaTaking people
- Allan Blair Cancer CentreRegina, CanadaTaking people
- Regional Health Authority B, Zone 2Saint John, CanadaTaking people
- Saskatoon Cancer CentreSaskatoon, CanadaTaking people
- Algoma District Cancer ProgramSault Ste. Marie, CanadaTaking people
- Niagara Health SystemSt. Catharines, CanadaTaking people
- Dr. H. Bliss Murphy Cancer CentreSt. John's, CanadaTaking people
- Thunder Bay Regional Health Sciences CentreThunder Bay, CanadaTaking people
- St. Joseph's Health CentreToronto, CanadaTaking people
- St. Michael's HospitalToronto, CanadaTaking people
- BCCA - VancouverVancouver, CanadaTaking people
- Windsor Regional Cancer CentreWindsor, CanadaTaking people
- CancerCare ManitobaWinnipeg, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Canadian Cancer Trials Group
- Trial code
- NCT06182774
- Record updated
- 14 October 2026
- Original description
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?Read full original descriptionShow less
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
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?
Inclusion: 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: 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.