Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

What this study is about

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?

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Cross Cancer Institute, Edmonton, Alberta, Canada
• 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

+ 16 more sites.

Who to contact

Annette Hay · 613-533-6430 · ahay@ctg.queensu.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06182774.