Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Mult… (NCT03500445) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma
United States75 participantsStarted 2019-02-13
Plain-language summary
The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy
• Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens does not disqualify the patient (the treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle of Proteasome Inhibitor / Immunomodulatory-based therapy)
* Both transplant and non-transplant candidates are eligible.
* Diagnosis of symptomatic multiple myeloma as per current International Myeloma Working Group (IMWG) uniform criteria prior to initial treatment
* Monoclonal plasma cells in the Bone Marrow (BM) ≥ 10% or presence of a biopsy-proven plasmacytoma
* Measurable disease, prior to initial treatment as indicated by one or more of the following:
* Serum M-protein ≥ 1 g/dL
* Urine M-protein ≥ 200 mg/24 hours
* If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
* Serum freelite measurable disease as per current IMWG criteria
* Bone marrow specimen will be required at study entry; available DNA sample from pre-induction BM will be used for calibration step for MRD evaluation by gene sequencing.
* Males and females ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate hepatic function, with …
What they're measuring
1
Rate of stringent complete response (sCR)
Timeframe: 8 months
2
Rate of minimal residual disease (MRD)-negative disease as assessed by Next Generation Sequencing