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

NCT ID NCT05338775

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This early-stage study tests whether combining two types of immune-boosting drugs (bispecific antibodies and a checkpoint inhibitor) is safe for people with multiple myeloma that has come back or stopped responding to treatment. About 74 participants will receive either talquetamab or teclistamab together with a PD-1 inhibitor. The main goal is to find safe doses and check for side effects, not to cure the 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

74 people

The number who actually took part.

Started

May 2022

Expected to finish

May 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: * Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit * Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level \>= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months) * Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant * Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis * Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Live, attenuated vaccine within 4 weeks before the first dose of study treatment * Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to Grade \<= 2) * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration

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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

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021, France

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Blavatnik Family Chelsea Medical Center at Mount Sinai

    New York, New York, 10011, United States

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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