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New drug cocktail aims to wipe out hidden myeloma cells after transplant

NCT ID NCT04876248

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 6 times

Summary

This phase 2 trial tests whether combining belantamab mafodotin (a targeted antibody-drug conjugate) with lenalidomide can eliminate minimal residual disease in multiple myeloma patients who still have detectable cancer after a stem cell transplant. The study enrolls 4 adults who are not yet cancer-free after transplant. The goal is to see if this approach can achieve undetectable cancer levels and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belantamab mafodotin and lenalidomide
What this could lead to
If successful, this could help more multiple myeloma patients achieve undetectable cancer levels after transplant, potentially improving long-term outcomes.
What could go wrong
This is a very small early-phase trial with only 4 participants, so results may not apply broadly. The drug combination also carries risks like eye problems and low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period * Female participants of childbearing potential are to have a negative serum pregnancy test within 24 hours before the first dose of study intervention * A male participant must agree to use an adequate method of contraception (as described below) during the treatment period and for at least 6 months after the last dose of study treatment to allow for clearance of any altered sperm, along with the following: * Refrain from donating sperm 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 * All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be =\< grade 1 at the time of enrolment except for alopecia * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Evidence of active bleeding requiring intervention within the last four weeks prior to first dose of study treatment * Current corneal epithelial disease except mild changes in corneal epithelium * Any major surgery within the last four weeks of first dose of study treatment * Use of contact lenses while participating in this study * Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment * Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Patients with isolated proteinuria resulting from MM are eligible * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with patient's safety or compliance to the study procedures * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if patient otherwise meets entry criteria * Malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction * Evidence of cardiovascular risk including any of the following: * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiography (EKG) abnormalities such as 2nd degree (type II) or 3rd degree atrioventricular (AV) block. * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within two months of first dose. * Class III or IV heart failure as defined by the New York Heart Association functional classification system. * Uncontrolled hypertension * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or lenalidomide * Active infection requiring antibiotic, antiviral, or antifungal treatment * Known human immunodeficiency virus (HIV) infection * Presence of hepatitis B surface antigen (HBsAg), at or within 3 months of registration Note: If Hepatitis B core antibody (HBcAb) present, see additional monitoring recommendations * Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at or within 3 months prior registration. Note: Patients with positive hepatitis C antibody due to prior resolved disease can be eligible, only if a confirmatory negative hepatitis C RNA test is obtained. * Note: Hepatitis RNA testing is optional and patients with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing * Best corrected visual acuity in the worst seeing eye worse than 20/100 (Snellen equivalent). Participants with vision worse than 20/100 due to a treatable condition (e.g., cataract) may be considered on an individual case basis within 6 months before registration * Use of an investigational drug within 14 days of first dose of study treatment or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of first dose of study treatment * Previously progressed on treatment with belantamab mafodotin * Pregnant or lactating female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.