S1803, Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study).
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years
- Registration Step 1 Except where otherwise indicated below that test is required in a shorter timeframe, all tests for establishing baseline disease status must be completed within 60 days prior to registration. All test results must be documented on the Baseline Tumor Assessment Form for Multiple Myeloma and the Onstudy Form
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Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT)
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Patients with disease measurable by serum light chain assay alone are eligible (defined as >/= 100 mg/L on involved light chain)
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Patients must be registered to Step 1 prior to registration to Step 2. Registration to Step 1 may take place prior to or after autologous stem cell transplant (ASCT), but after completion of induction therapy
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Patients must have initiated induction therapy within 12 months prior to registration Step 1 and have received at least two cycles of induction therapy
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Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation)
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Please contact study team for more eligibility criteria
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- Patients with smoldering myeloma are not eligible. Patients with purely non-secretory MM as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible. Patients must have measurable M protein in the serum (defined as >/= 0.5g/dL) or urine (defined as >/= 200 mg/24h). Patients with plasma cell leukemia are not eligible
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Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction
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Patients must not have progressive disease at any time prior to registration
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Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20
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Patients must not be intolerant to either lenalidomide or daratumumab/rHuPH20
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Patients must not have received any investigational agents within 14 days prior to registration
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Please contact study team for more eligibility criteria
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Angiogenesis Modulating Agents
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Immunoproliferative Disorders
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Lymphoproliferative Disorders
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Neoplasms by Histologic Type
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Physiological Effects of Drugs
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