Protocol – ECOG – 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:
- Must be at least 18 years of age.
- ECOG Performance Status 0-2.
- 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.
- 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.
- Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
- 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. - Patient must have measurable or evaluable disease.
- 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. - 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.
- 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.