Protocol: SWOG – S1803
Please Note: Below is partial eligibility, for full eligibility requirements, please contact the Genesys Hurley Cancer Institute Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!
- Patients must have had a confirmed diagnosis of symptomatic multiple myeloma with measurable disease at the time of myeloma diagnosis that required systemic induction therapy prior to autologous stem cell transplantation. Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as ≥ 10 mg/dL [≥100 mg/L] on involved light chain) at the time of diagnosis. Patients with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma. Patients with purely non-secretory MM at the time of diagnosis as measured by electrophoresis and immunofixation and the absence
of Bence Jones proteins in the urine are not eligible. Patients with plasma cell leukemia are not eligible. Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. Patients must not have progressive disease at any time prior to registration.
- Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20. Patients must not be intolerant to the starting dose of either lenalidomide (10 mg) or daratumumab/rHuPH20. Patients intolerant to the 25 mg starting dose of lenalidomide are eligible. Patients who have already received transplant must have initiated induction therapy within 18 months prior to transplant and received at least two cycles of induction therapy before transplant. Patients who have not already received transplant must have begun induction therapy within 18 months prior to the planned date of transplant and must receive at least two cycles of induction therapy before transplant. 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. Patients who have completed ASCT may be registered to Step 1 and Step 2 on the same day, provided all eligibility criteria are met. Patients must not have received any investigational agents within 14 days prior to registration.
- Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1. Patients must have history and physical exam within 28 days prior to registration. Patients must have Zubrod Performance Status ≤ 2.
- Patients must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug
(e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- For patients who have not yet received transplant: Patients must be willing and able to return to a participating treatment center for their assigned treatment after randomization. Note that patients need not have a direct relationship with the transplant center in order to register.