Protocol: ECOG – EAA171

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA EAA171

  1. Must be at least 18 years of age.
  2. Patient must be previously diagnosed with multiple myeloma (MM) and be on lenalidomide maintenance with ≥ 10mg daily dose (≥5 mg for patients with creatinine clearance 30-60 mL/min) for at least 10 months and no more than 15 months after an early autologous stem cell transplantation (SCT ≤ 12 months of diagnosis). Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on Step 1 of this protocol.
  3. Patient must be able to undergo a diagnostic bone marrow aspirate following pre-registration to Step 0.
  4. ECOG Performance Status 0-2.
  5. Patient must not have another malignancy requiring treatment or have received treatment within 2 years before pre-registration or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  6. Patient must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide including difficulty swallowing.


February 22, 2021 Hematology/Multiple Myeloma

Protocol – ECOG – EAA181

Please Note Below is a partial list of the eligibility, please contact the GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038 for full eligibility requirements.

Eligibility:

SCHEMA EA5181

  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: ECOGEAA173

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA EAA173

  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.

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