New cocktail of drugs aims to tackle multiple myeloma early
NCT ID NCT05695508
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
11 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGHamburg, 22763, Germany
-
Charité University Medicin Berlin
RECRUITINGBerlin, 12203, Germany
-
Clinic Chemnitz gGmbH
RECRUITINGChemnitz, 09113, Germany
-
Hamburg University Clinic Eppendorf
RECRUITINGHamburg, 20246, Germany
-
Technical University Munich
RECRUITINGMunich, 81675, Germany
-
University Clinic Düsseldorf
RECRUITINGDüsseldorf, 40225, Germany
-
University Clinic Freiburg
RECRUITINGFreiburg im Breisgau, 79106, Germany
-
University Clinic Schleswig-Holstein Campus Kiel
RECRUITINGKiel, 24105, Germany
-
University Clinic Technical University Dresden
RECRUITINGDresden, 01307, Germany
-
University Hospital Heidelberg
RECRUITINGHeidelberg, 69120, Germany
-
University Würzburg
RECRUITINGWürzburg, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas