Study on Maintenance Therapy with Belantamab Mafodotin and Lenalidomide After Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05091372
This clinical trial is exploring whether a combination of two drugs, belantamab mafodotin and lenalidomide, can help improve outcomes for patients with newly diagnosed multiple myeloma after they have undergone a stem cell transplant.
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Program Overview
The aim of this study is to see if using belantamab mafodotin and lenalidomide as maintenance therapy can help patients with newly diagnosed multiple myeloma achieve a better response after a stem cell transplant. The study will also look at the safety of this treatment and how it affects the length of time patients remain free from disease progression and their overall survival.
Description
The main goal of this study is to increase the number of patients who achieve a complete response without any detectable cancer cells (MRD-negative) after receiving maintenance therapy with belantamab mafodotin and lenalidomide following a stem cell transplant.
Secondary goals include:
- Evaluating the safety and side effects of the treatment.
- Increasing the overall rate of complete response without detectable cancer cells.
- Determining how long patients remain free from disease progression and their overall survival after stopping maintenance therapy if they achieve a sustained complete response.
- Assessing the progression-free survival (PFS) and overall survival (OS) with this maintenance therapy.
Eligibility Criteria
Inclusion Criteria
- Patients with newly diagnosed multiple myeloma who have had their first stem cell transplant 60 to 180 days ago.
- Must have a partial response or better to treatment, with or without minimal residual disease (MRD).
- Aged between 18 and 75 years old.
- Must have a performance status score of 70 or higher, indicating they are able to care for themselves.
- Must have adequate organ function.
- Must agree not to donate blood while taking lenalidomide and for 28 days after stopping it.
- Must enroll in the lenalidomide REMS program.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
- Men must agree to use contraception and refrain from donating sperm during treatment and for 6 months after the last dose.
- All side effects from the stem cell transplant must be mild or resolved, except for hair loss, fatigue, and missed periods.
Exclusion Criteria
- History of disease progression before starting maintenance therapy.
- Patients with smoldering multiple myeloma or plasma cell leukemia.
- Patients with non-secretory multiple myeloma unless measurable by PET scan or bone marrow.
- Unstable liver or kidney conditions.
- Current eye conditions or use of contact lenses.
- Recent use of investigational drugs or certain treatments.
- Recent major surgery.
- Active bleeding or infection.
- Known allergies to study drugs.
- Cardiovascular issues like uncontrolled arrhythmias or recent heart attack.
- Known HIV infection.
- Hepatitis B or C infection unless specific criteria are met.
- Other active cancers unless stable for at least 2 years.
- Pregnant or breastfeeding women.
- Cognitive impairments or serious medical or psychiatric conditions that could interfere with the study.
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