Status and phase
Conditions
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About
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?
Full description
The usual approach for people with myeloma who are not having a stem cell transplant is treatment with the combination of daratumumab, lenalidomide, and dexamethasone. These drugs are given continuously until they are no longer effective or cause major side effects.
Those that decide to take part in this study, will be randomly placed in one of two groups. If in the usual care group, patients will continue all the myeloma medicines currently being taken. If in the experimental group, patients will stop the daratumumab injection, and continue taking the myeloma tablets currently being taken. Regardless of which group, patients will stay on treatment indefinitely as long they are benefiting from it.
Enrollment
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Inclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
559 participants in 2 patient groups
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Central trial contact
Annette Hay
Data sourced from clinicaltrials.gov
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