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New cocktail of drugs takes on multiple myeloma

NCT ID NCT04108195

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This early-stage trial tests combinations of the drug daratumumab with two newer bispecific antibodies (talquetamab and teclistamab), with or without pomalidomide, in 290 people with multiple myeloma. The main goal is to find safe doses and understand side effects. Participants must have had at least three prior treatments.

What this could mean

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

Active substance
daratumumab, talquetamab, teclistamab, pomalidomide
What this could lead to
If successful, this could point toward a new combination treatment for multiple myeloma that is more effective than current options.
What could go wrong
This is an early Phase 1b study focused on safety and dosing, not yet on effectiveness. The combinations may cause serious side effects or fail to work better than existing therapies.

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

290 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Apr 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: * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to \[\>=\] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (\>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD * Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level \>=1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level \>=0.5 g/dL); or Urine M-protein level \>=200 milligrams (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose * Female participants of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than \[\<\] 5 international units per milliliter \[IU/mL\]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug Exclusion Criteria: * Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy * Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor * Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded * Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing

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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

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Germans Trias I Pujol

    Barcelona, 08916, Spain

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908, Spain

  • LUMC

    Leiden, 2333ZA, Netherlands

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, 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 Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

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