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New hope for Tough-to-Treat myeloma: DREAMM 7 trial tests powerful combo

NCT ID NCT04246047

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new combination of drugs (belantamab mafodotin, bortezomib, and dexamethasone) against a standard combo (daratumumab, bortezomib, and dexamethasone) in 494 people whose multiple myeloma has come back or stopped responding to treatment. The goal is to see if the new combo can delay cancer growth longer. Participants must have had at least one prior therapy and have measurable disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

494 people

The number who actually took part.

Started

May 2020

Expected to finish

Jun 2028

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: * Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. * Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Must have at least 1 aspect of measurable disease, defined as one of the following; 1. Urine M-protein excretion \>=200 mg per 24-hour, or 2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or 3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * 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 enrollment, except for alopecia. * Adequate organ function Exclusion Criteria: * Intolerant to daratumumab. * Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). * Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. * Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. * Prior allogenic stem cell transplant. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * Corneal epithelial disease.

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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

  • GSK Investigational Site

    Yuma, Arizona, 85364, United States

  • GSK Investigational Site

    Denver, Colorado, 80218, United States

  • GSK Investigational Site

    Kansas City, Kansas, 66205, United States

  • GSK Investigational Site

    Fairfield, Ohio, 45242, United States

  • GSK Investigational Site

    Tyler, Texas, 75702, United States

  • GSK Investigational Site

    Liverpool, New South Wales, 2170, Australia

  • GSK Investigational Site

    Wollongong, New South Wales, 2500, Australia

  • GSK Investigational Site

    Benowa, Queensland, 4217, Australia

  • GSK Investigational Site

    Brussels, 1090, Belgium

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Roeselare, 8800, Belgium

  • GSK Investigational Site

    Beijing, 100191, China

  • GSK Investigational Site

    Jinan, 250012, China

  • GSK Investigational Site

    Shenyang, 110001, China

  • GSK Investigational Site

    Alexandroupoli, 68 100, Greece

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Thessaloniki, 54007, Greece

  • GSK Investigational Site

    Tel Aviv, 64239, Israel

  • GSK Investigational Site

    Bergamo, 24127, Italy

  • GSK Investigational Site

    Meldola FC, 47014, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Aichi, 441-8570, Japan

  • GSK Investigational Site

    Aichi, 467-8602, Japan

  • GSK Investigational Site

    Aomori, 030-8553, Japan

  • GSK Investigational Site

    Ehime, 790-8524, Japan

  • GSK Investigational Site

    Fukuoka, 806-8501, Japan

  • GSK Investigational Site

    Fukuoka, 807-8555, Japan

  • GSK Investigational Site

    Fukuoka, 810-8563, Japan

  • GSK Investigational Site

    Fukuoka, 815-8555, Japan

  • GSK Investigational Site

    Gifu, 503-8502, Japan

  • GSK Investigational Site

    Gunma, 377-0280, Japan

  • GSK Investigational Site

    Hyōgo, 670-8540, Japan

  • GSK Investigational Site

    Kanagawa, 221-0855, Japan

  • GSK Investigational Site

    Kanagawa, 247-8533, Japan

  • GSK Investigational Site

    Kochi, 781-8555, Japan

  • GSK Investigational Site

    Nagano, 392-8510, Japan

  • GSK Investigational Site

    Okayama, 701-1192, Japan

  • GSK Investigational Site

    Osaka, 530-0012, Japan

  • GSK Investigational Site

    Osaka, 545-8586, Japan

  • GSK Investigational Site

    Shizuoka, 411-8777, Japan

  • GSK Investigational Site

    Dordrecht, 3318 AT, Netherlands

  • GSK Investigational Site

    Groningen, 9713 GZ, Netherlands

  • GSK Investigational Site

    Chorzów, 41-500, Poland

  • GSK Investigational Site

    Krakow, 30510, Poland

  • GSK Investigational Site

    Lodz, 93-513, Poland

  • GSK Investigational Site

    Lublin, 20-081, Poland

  • GSK Investigational Site

    Lublin, 20-090, Poland

  • GSK Investigational Site

    Nowy Sącz, 33-300, Poland

  • GSK Investigational Site

    Poznan, 60-569, Poland

  • GSK Investigational Site

    Warsaw, 02-781, Poland

  • GSK Investigational Site

    Moscow, 125284, Russia

  • GSK Investigational Site

    Nizhny Novgorod, 603126, Russia

  • GSK Investigational Site

    Novosibirsk, 630087, Russia

  • GSK Investigational Site

    Saint Petersburg, 191024, Russia

  • GSK Investigational Site

    Saint Petersburg, 197 089, Russia

  • GSK Investigational Site

    Saratov, 410028, Russia

  • GSK Investigational Site

    Ufa, 450083, Russia

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Ulsan, 44033, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08916, Spain

  • GSK Investigational Site

    Cáceres, 10003, Spain

  • GSK Investigational Site

    Gijón, 33394, Spain

  • GSK Investigational Site

    L'Hospitalet de Llobrega, 08908, Spain

  • GSK Investigational Site

    Murcia, 30008, Spain

  • GSK Investigational Site

    PamplonaNavarra, 31008, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

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