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NCT05091372
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Conditions: Myeloma Multiple
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 94
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.
Eligibility Criteria
Inclusion Criteria:
* Patients with newly diagnosed multiple myeloma status post 1st auto-HCT (day 60 - 180 post-transplant).
* Disease status (MRD positive or negative), partial response, or better.
* Age \> 18-year and 75-year. Non-English speaking patients are eligible.
* Karnofsky performance status 70 (Appendix A.).
* Adequate organ function (Please see Table 2. below). Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide.
* Patient agrees to enroll in the lenalidomide REMS program.
* Woman of child-bearing potential (WOCPB) must abstain from hetersosexual sexual contact or agrees to use a contraceptive method that is highly effective (with a failure rate of \1 year.
* Patients who have been amenorrhoeic for \
Source: ClinicalTrials.gov (NCT05091372). StuddyBuddy aggregates publicly available trial information.