Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Mini… (NCT04876248) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant
United States4 participantsStarted 2024-08-19
Plain-language summary
This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years of age at time of consent
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG), 2016 criteria, and
* Patient is considered transplant eligible, and
* Is not MRD negative complete response (CR) after high dose chemotherapy
* Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L (within 14 days of first dose of study treatment)
* Hemoglobin \>= 8.0 g/dL (within 14 days of first dose of study treatment)
* Platelets \>= 75 X 10\^9/L (within 14 days of first dose of study treatment)
* Total bilirubin =\< 1.5 X upper limit of normal (ULN) (isolated bilirubin \>= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) (within 14 days of first dose of study treatment)
* Alanine aminotransferase (ALT) =\< 2.5 X ULN or \< 5 times ULN if documented liver infiltration (within 14 days of first dose of study treatment)
* Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ 1.73 m\^2 (within 14 days of first dose of study treatment)
* Spot urine (albumin/creatinine ratios (spot urine) \< 500 mg/g (56 mg/mmol) OR urine dipstick Negative/trace (if \>= 1+ only eligible if confirmed =\< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) (within 14 days of first dose of study treatment)
* A female participant is eligible to part…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimal residual disease (MRD) negative rate
Timeframe: After 6 cycles of post-transplant consolidation with belantamab mafodotin and lenalidomide (1 cycle = 8 weeks)