Protocol: SWOG – S1803

Schema – 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!

Eligibility:

1. 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.
2. 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.
3. 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.
4. 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).
5. 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.
6. 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.

Protocol – ECOG – EAA181

Schema – EAA181

Please Note – Below is partial eligibility, for the full eligibility requirement’s, please contact the GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Must be at least 18 years of age.
2. ECOG Performance Status 0-2.
3. Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of treatment.  Note: Patient does not need to have bone marrow evaluation prior to Step 0 pre-registration. Bone marrow evaluation may be deferred to after Step 0 pre-registration to confirm presence of >10% clonal bone marrow plasma cells per IMWG criteria.
4. Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later. Note: Stem cell collection is allowed on study.
5. Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
6. Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.  Note:R-ISS Stage is based on serum β2 microglobulin, albumin and LDH levels along with presence of chromosomal
   abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk.
7. Patient must have measurable or evaluable disease.
8. Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study
   requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration.
9. Patients who have received prior treatment for smoldering multiple myeloma (SMM) are eligible, except those whohave received prior treatment with lenalidomide in combination with an anti-CD38 monoclonal antibody.
10. Patients 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 the investigational regimen are eligible for this trial.

Protocol: ECOG – EAA173

Schema – EAA173

Please Note: Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
2. A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
3. SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
4. Patient must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN). Specifically, local interpretation of MRI and PET scans will be used to exclude lytic lesions or plasmacytomas and must be obtained within 60 days prior to randomization.
5. Patient must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patient must also not have contraindication to DVT prophylaxis/aspirin.
6. Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.