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New drug combo aims to tackle Hard-to-Treat myeloma

NCT ID NCT07084896

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, belantamab mafodotin and nirogacestat, in people with multiple myeloma that has returned or not responded to at least three prior treatments. The goal is to find a safe dose and see how well the combination shrinks tumors. About 106 adults are taking part in this early-phase trial.

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 nirogacestat
What this could lead to
If it works, this combination could offer a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 106 participants, so results may not apply to everyone. Side effects like low blood counts and eye problems are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

106 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Participant must be 18 years of age inclusive or older, at the time of signing the informed consent. * Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG. * Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody. * Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was \>100 days prior to study enrolment and with no active infection(s). * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (\<=)2 is due solely to skeletal complications and/or skeletal pain due to MM. * Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (\>=)0.5 gram per deciliter (\>=5 gram per liter) or Urine M-protein \>=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level \>=10 mg per deciliter (\>=100 mg per Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening. * Participants who are currently receiving physiological doses oral steroids (\<10 mg/day), inhaled steroids or ophthalmological steroids. Exclusion Criteria: Participants with current corneal epithelial disease except mild punctate keratopathy. * Participants with evidence of cardiovascular risk. * Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb. * Participants with active infection requiring antibiotic, antiviral, or antifungal treatment. * Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days. * Participants with prior radiotherapy within 2 weeks of start of study therapy. * Participants with prior allogeneic transplant are prohibited. * Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening. * Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days. * Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter. * Participants with \>=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation. * Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug. * Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment. * Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM. * Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load\<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts \>= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only. * Participants with uncontrolled small and/or large intestinal disease. * Participants with uncontrolled skin disease. * Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement. * Participants with previous administration of a gamma secretase inhibitor. * Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • 238995

    Atlanta, Georgia, 30322, United States

  • 239015

    Madison, Wisconsin, 53792, United States

  • 240593

    Boston, Massachusetts, 02215, United States

  • 251164

    Grand Rapids, Michigan, 49546, United States

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z1M9, Canada

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Villejuif, 94805, France

  • GSK Investigational Site

    Frankfurt, 60590, Germany

  • GSK Investigational Site

    Kiel, 24105, Germany

  • GSK Investigational Site

    Leipzig, 04103, Germany

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    Oslo, 0450, Norway

  • GSK Investigational Site

    Katowice, 40-519, Poland

  • GSK Investigational Site

    Lodz, 93-513, Poland

  • GSK Investigational Site

    Lublin, 20-081, Poland

  • GSK Investigational Site

    Moscow, 125284, Russia

  • GSK Investigational Site

    Incheon, 21565, South Korea

  • GSK Investigational Site

    Seoul, 06351, South Korea

  • GSK Investigational Site

    Seoul, 06591, South Korea

  • GSK Investigational Site

    Ulsan, 44033, South Korea

  • GSK Investigational Site

    Badalona, 08916, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 31008, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Falun, SE-791 82, Sweden

  • GSK Investigational Site

    Stockholm, SE-141 86, Sweden

More trials for these conditions

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