Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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% per year), preferably with low user dependency (as described in Appendix C), plus one additional effective method at least 28 days before starting therapy (for lenalidomide), during the intervention period, at least 28 days after the last dose of lenalidomide and at least 4 months after the last dose of belantamab mafodotin, and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention.

⁃ A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 10-14 days and also within 24 hours before the first dose of the study intervention.

⁃ Nonchildbearing potential is defined as follows (by other than medical reasons):

• ≥ 45 years of age and has not had menses for \>1 year.

• Patients who have been amenorrhoeic for \<2 years without a history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.

• Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. 9. Male participant agrees to contraceptive use that should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.

⁃ Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:

⁃ • Refrain from donating sperm during treatment (including dose interruptions) and for 4 weeks after their last dose of lenalidomide.

⁃ PLUS, either:

⁃ • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

⁃ OR Must agree to use contraception/barrier as detailed in Appendix C.

⁃ • All prior auto-HCT- related toxicities (defined by National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5 must be ≤ Grade 1 at the time of enrollment except for alopecia, fatigue, and amenorrhea.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Qaiser Bashir
qbashir@mdanderson.org
(713) 794-4422
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 94
Treatments
Experimental: Belantamab mafodotin
belantamab mafodotin by vein over about 30 minutes on Day 1 of each cycle
Experimental: Lenalidomide
lenalidomide by mouth every day of each cycle
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov