Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma

• Status: Recruiting
• Trial end date: 2032-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Currently, daratumumab, lenalidomide, and dexamethasone are given continuously (non-stop). Some recent observations suggest that stopping daratumumab after about a year and a half of treatment may work just as well as giving it continuously with lenalidomide and dexamethasone. This study is being done to answer the question: is less daratumumab treatment as good as more?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Cancer Trials Group
• Collaborators: Canadian Institutes of Health Research (CIHR); Myeloma Canada
• Treatments: Daratumumab; Dexamethasone; Lenalidomide

Criteria

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 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

• Received daratumumab-lenalidomide-dexamethasone for 18-20 cycles

• 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.