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NCT06207799
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Conditions: Multiple Myeloma, Post-transplant MRD-guided Maintenance Therapy, Pre-transplant Purging
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.
Eligibility Criteria
Inclusion Criteria:
1. Transplant eligible patients with newly diagnosed multiple myeloma (NDMM).
2. High-risk multiple myeloma\*
3. Participants with disease response ≥ PR to induction therapy
4. Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible.
5. Karnofsky performance status ≥70 (Appendix A).
6. Adequate liver function (total bilirubin ≤1.5X ULN; ALT ≤2.5 X ULN)
7. Estimated creatinine clearance ≥40 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, estimated glomerular filtration rate (Modification of Diet in Renal Disease \[MDRD\]), or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula). \*
8. Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide.
9. Participant agrees to enroll in the lenalidomide REMS program.
10. Women of child-bearing potential (WOCPB) must abstain from heterosexual intercourse or agree to use a contraceptive method that is highly effective (with a failure rate of \1 year.
* Participants who have been amenorrhoeic for \
Source: ClinicalTrials.gov (NCT06207799). StuddyBuddy aggregates publicly available trial information.