Trial studying safety and effects for Multiple Myeloma
Official title A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
ClinicalTrials.gov ID: NCT07227311
What this study is testing
What is Belantamab mafodotin?
This is an investigational medicine being studied as a potential treatment for multiple myeloma. It is designed to attach to a specific protein on the surface of myeloma cells to help the body target and destroy them.
Also referred to as Blenrep.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if giving the drug less often works well and causes fewer eye problems. It also checks how safe the treatment is.
- Who it's for
- Adults with multiple myeloma (a blood cancer) that has come back or is not responding to current treatment.
- What's involved
- Participants will receive the study drug along with other standard cancer medicines. They will have regular visits for tests to monitor their health and any side effects.
- Time commitment
- The study involves ongoing visits for the duration of the treatment and follow-up, though the exact total time is not specified.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, 18 years or older (at the time consent is obtained).
- Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.
- Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or...
- Urine M-protein excretion ≥200 mg/24 h, or
You likely can't join if
- Active plasma cell leukemia at Screening.
- Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes...
- The disease must be considered medically stable for at least 2 years; or
- The patient must not be receiving active therapy, other than hormonal therapy for this disease.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab...
- Plasmapheresis within 7 days prior to the first dose of study intervention.
See the full eligibility criteria
- Male or female, 18 years or older (at the time consent is obtained).
- Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.
- Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.
- Urine M-protein excretion ≥200 mg/24 h, or
- Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
- Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\ 1.65) only if patient has no measurable urine or serum M spike.
- ASCT was \>100 days prior to the first dose of study medication,
- No active bacterial, viral, or fungal infection(s) present.
- All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.
- Adequate organ system functions as defined by the laboratory assessments.
- Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.
- Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.
- Active plasma cell leukemia at Screening.
- Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).
- The disease must be considered medically stable for at least 2 years; or
- The patient must not be receiving active therapy, other than hormonal therapy for this disease.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
- Plasmapheresis within 7 days prior to the first dose of study intervention.
- Patients after prior allogeneic stem cell transplant
- Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.
- Evidence of active mucosal or internal bleeding.
- Intolerance or contraindications to anti-viral prophylaxis.
- Current corneal epithelial disease except for mild punctate keratopathy.
- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.
- Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety).
- Received prior B-cell maturation antigen (BCMA)-targeted therapy.
- Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications.
- HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.
- Significant liver dysfunction (ALT \>2.5x ULN, bilirubin \>1.5x ULN, cirrhosis, unstable liver/biliary disease).
- Positive hepatitis B or C markers unless criteria for resolved infection are met.
- Received prior treatment with or intolerant to pomalidomide.
- Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m² twice weekly or within 60 days of completing that treatment).
- Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).
- Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.
- Left ventricular ejection fraction \<40% as assessed by transthoracic echocardiogram.
- Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.
- Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- Known pulmonary hypertension.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Alamitos, California, United States
- Torrance, California, United States
- Whittier, California, United States
- Norwich, Connecticut, United States
- Fort Myers, Florida, United States
- Macon, Georgia, United States
- Baton Rouge, Louisiana, United States
- Bethesda, Maryland, United States
- Bridgeton, Missouri, United States
- Springfield, Missouri, United States
- Farmington, New Mexico, United States
- Nashville, Tennessee, United States
- Dunkirk, Nord, France
- Nantes, France
- Paris, France
- Saint-Etienne, France
- Frankfurt, Germany
- Hamburg, Germany
- Karlsruhe, Germany
- Koblenz, Germany
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Alamitos, California, United States; Torrance, California, United States; Whittier, California, United States; Norwich, Connecticut, United States; Fort Myers, Florida, United States; Macon, Georgia, United States and 46 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.