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?
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
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.
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
Parallel
Daratumumab
DrugDose determined at enrollment
Lenalidomide
DrugDose determined at enrollment
Dexamethasone
DrugDose determined at enrollment
Isatuximab
DrugDose determined at enrollment
Progression-Free Survival
PFS is defined as the time from date of enrollment to date of first documentation of disease progression
Overall Survival
Time from enrollment to death from any cause
Partial Response or Better as assessed by IMWG Criteria
Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0
Time to Next Treatment
Time from enrollment to the start of next-line treatment
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Canadian Cancer Trials Group
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Myeloma Canada
Collaborator
