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New cocktail of drugs aims to tackle multiple myeloma early

NCT ID NCT05695508

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing several new drug combinations, including teclistamab, talquetamab, and JNJ-79635322, in 160 people newly diagnosed with multiple myeloma who are eligible for a stem cell transplant. The goal is to see if these combinations are safe and more effective than current treatments at controlling the disease before and after transplant. Participants will receive different drug regimens to find the best approach.

What this could mean

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

Active substance
Teclistamab, talquetamab, JNJ-79635322, daratumumab, lenalidomide, bortezomib, and dexamethasone
What this could lead to
If successful, this could lead to more effective and safer treatment combinations for newly diagnosed multiple myeloma, potentially improving remission rates and reducing the need for intensive chemotherapy and stem cell transplant.
What could go wrong
This is an early-phase (Phase 2) trial with a small number of participants (160), so results may not apply to all patients. The drug combinations may cause significant side effects, and it's uncertain if they will outperform current standard treatments.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

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 to 70 years

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: \- 18 years of age to 70 years of age, inclusive * Have an ECOG performance status score of 0 to 2 at screening * Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment Participants in Arms A, A1, B, D, E, E1, F, F1 and G must also satisfy all of the following criteria to be enrolled in the study: 1\. Documented multiple myeloma requiring treatment as defined by the criteria below: 1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria 2. Measurable disease at screening as defined by any of the following: 1\. Serum M-protein level ≥1.0 g/dL or 2. Urine M-protein level ≥200 mg/24 hours or 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio 2. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D and G participants). Participants Arm C and C2 must also satisfy all of the following criteria: 1. Newly diagnosed multiple myeloma according to IMWG criteria. 2. Must have received 4 to 6 28-day cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6. 3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria for ≥PR based on repeat imaging utilizing the same modality 4. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment. Exclusion Criteria: \- CNS involvement or clinical signs of meningeal involvement of multiple myeloma. \- Stroke or seizure within 6 months prior study start Cycle1 Day1. \- History of transplantations requiring immunosuppressive therapy. \- Seropositive for HIV, HEP B, Active Hep C infection (details see protocol). \- COPD with a FEV1 \<50% of predicted normal. \- Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 \<50% of predicted normal. \- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants. \- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients. \- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of any study treatment regimen. \- Plans to father a child while enrolled in this study or within 100 days after the last dose of any component of the study treatment regimen. Arm A, A1, B, D, E, E1, F, F1 * Prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. * Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version 5. Due to a potential interaction with bortezomib, received a strong CYP3A4 inducer within 5 half-lives prior to enrollment Arm C and C2 \- Discontinued treatment due to any AE related to lenalidomide as determined by the investigator. * Progressed on multiple myeloma therapy at any time prior to screening. * Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration. * Intolerant to the starting dose of lenalidomide (10 mg). For further details on inclusion/exclusion criteria please refer to the study protocol.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Clinic Hamburg Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Charité University Medicin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Clinic Chemnitz gGmbH

    RECRUITING

    Chemnitz, 09113, Germany

  • Hamburg University Clinic Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Technical University Munich

    RECRUITING

    Munich, 81675, Germany

  • University Clinic Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • University Clinic Freiburg

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • University Clinic Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

  • University Clinic Technical University Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • University Würzburg

    RECRUITING

    Würzburg, Germany

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