Actively Recruiting
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
94
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed multiple myeloma status post first autologous hematopoietic cell transplant between day 60 and 180 post-transplant.
- Disease status is MRD positive or negative, with partial response or better.
- Age between 18 and 75 years.
- Karnofsky performance status of 70 or higher.
- Adequate organ function as defined in study criteria.
- Agreement to not donate blood during lenalidomide treatment and for 28 days after stopping.
- Enrollment in the lenalidomide REMS program.
- Women of child-bearing potential must use effective contraception and have negative pregnancy tests before and during treatment.
- Male participants must agree to contraceptive use or abstinence during treatment and for six months after last dose.
- All prior transplant-related toxicities must be grade 1 or less, except alopecia, fatigue, and amenorrhea.
You will not qualify if you...
- History of progressive disease before starting maintenance therapy.
- Diagnosis of smoldering multiple myeloma.
- Presence of plasma cell leukemia.
- Non-secretory multiple myeloma without measurable disease.
- Unstable liver or biliary disease.
- Active renal conditions affecting safety.
- Current corneal or epithelial disease beyond mild keratopathy.
- Use of contact lenses during study participation.
- Use of investigational drugs or systemic anti-myeloma therapy within 14 days before study drug.
- Prior monoclonal antibody treatment within 30 days before study drug.
- Major surgery within 4 weeks before starting treatment.
- Active mucosal or internal bleeding.
- Known hypersensitivity to study drugs or components.
- Active infection requiring treatment.
- Significant cardiovascular risks including uncontrolled arrhythmias or heart failure.
- Known HIV infection.
- Active hepatitis B or C infection not meeting specific criteria.
- Invasive malignancies other than multiple myeloma unless stable for at least 2 years.
- Pregnancy or lactation.
- Cognitive impairment or unstable psychiatric or medical conditions interfering with safety or consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77051
Actively Recruiting
Research Team
Q
Qaiser Bashir
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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