Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
• At least 18 years of age
• Ability to understand and willingness to sign an IRB approved written informed consent document. (Legally authorized representatives may sign and give informed consent on behalf of study participants.)
• Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma. Frontline therapy in this setting is defined as treatment received prior to first relapse and may include multiple lines of therapy per the Rajkumar et al definition if treatment changes were made for either toxicity or inadequate response to initial induction.
• Received frontline treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
• Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
• MRD-positive on Day 100 landmark assessment (80 to 160 days after AHCT), defined as \>1 x 10-5 myeloma cells/cell by clonoSEQ assay (Adaptive Biotechnologies, Seattle, WA) performed on bone marrow aspirate.
• ECOG performance status ≤ 2
• All toxicities from prior treatment should have resolved to Grade ≤ 1 prior to enrollment.
• Adequate bone marrow and organ function within 28 days prior to start of treatment as defined below:
‣ Platelets ≥ 75 k/cumm
⁃ Absolute neutrophil count ≥ 1.0 k/cumm
⁃ Hemoglobin ≥ 8 g/dL without the use of growth factors or transfusion for at least 2 weeks.
⁃ Total bilirubin ≤ 2 × upper limit of normal (ULN; ≤ 3 x ULN if documented Gilbert's syndrome)
⁃ Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
⁃ Creatinine clearance ≥ 30 ml/min.
• The effects of elranatamab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.