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

Launched by CANADIAN CANCER TRIALS GROUP · Dec 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different ways to use a medication called daratumumab in older adults who have just been diagnosed with multiple myeloma and are not able to undergo a stem cell transplant. Currently, patients receive daratumumab along with two other medications continuously, but this study is exploring whether stopping daratumumab after about 18 months is just as effective as taking it continuously. The goal is to determine if receiving less daratumumab can provide similar benefits for patients.

To participate in this trial, patients must be between the ages of 65 and 74, have newly diagnosed multiple myeloma, and have measurable disease at the time of diagnosis. Participants should have already received treatment with daratumumab, lenalidomide, and dexamethasone for about 18 to 20 cycles and need to show at least a partial response to treatment. During the trial, patients will receive regular treatment and will be asked to complete questionnaires about their quality of life. It’s important for potential participants to discuss this trial with their doctor to see if it’s a good fit for them.

Gender

ALL

Eligibility 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.