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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed multiple myeloma who cannot have a stem-cell transplant. They must have finished 18-20 cycles of daratumumab or isatuximab with lenalidomide and dexamethasone and responded to it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed multiple myeloma, not able to have a transplant, with measurable disease at diagnosis and at least a partial response to treatment; ECOG performance status 0-3
- Earlier treatment
- Must have completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone
- Biomarker or test result
- Measurable disease at diagnosis, for example serum M-protein of 5 g/L or more, or urine M-protein of 200 mg/24 hours or more
Main reasons for not taking part
- Known amyloid light chain amyloidosis, POEMS syndrome or Waldenstrom's macroglobulinemia
- Other anti-cancer treatment at the same time that would affect following the trial treatment
- Active, uncontrolled bacterial, fungal or viral infection within 7 days before enrolment
- HIV with a CD4 count below 350 cells/microliter
Read by machine on 11 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.