New hope for frail myeloma patients: shorter drug combo trial launches
NCT ID NCT07107529
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two drug combinations (teclistamab plus daratumumab or talquetamab plus daratumumab) in 150 frail patients newly diagnosed with multiple myeloma. The goal is to see if these fixed-duration treatments can control the cancer for at least 18 months. Participants receive injections under the skin and are monitored for side effects and disease progression.
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, and daratumumab (drugs given as injections under the skin)
- What this could lead to
- If successful, this could offer a fixed-duration treatment option that controls multiple myeloma in frail patients who are often too weak for standard therapies.
- What could go wrong
- This is a Phase 2 trial with only 150 participants, so results are preliminary. The drugs may cause side effects like infections or allergic reactions, and the treatment may not work for everyone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 2034
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study 2. Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria 3. Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL \[≥100 mg/L\] and abnormal serum immunoglobulin kappa/lambda FLC ratio 4. Frail according to the Simplified IMWG frailty index 5. Have clinical laboratory values meeting defined range 6. Patients of childbearing potential must agree to use adequate/highly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug Exclusion Criteria: 1. Non-secretory MM or measurable disease by urine or plasmacytoma only 2. Central nervous system involvement of myeloma 3. Significant pulmonary dysfunction 4. Stroke, transient ischemic attack, or seizure within 6 months of eligibility 5. Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy 6. HIV and Hepatitis infections 7. Exclude for any of the following: 1. Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity. 2. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. 8. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility 9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI) 10. Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility 11. Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to \>40 mg dexamethasone within the 14 days prior to C1D1 12. Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed 13. Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing 14. Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery 15. Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device \<4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected 16. Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study 17. Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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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.
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The places running it
29 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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ES-Barcelona-H.U. Vall d'Hebrón [06-002]
NOT_YET_RECRUITINGBarcelona, Spain
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ES-Las Palmas-H.U. de Gran Canaria Dr Negrín [06-030]
NOT_YET_RECRUITINGLas Palmas, Spain
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ES-Murcia-H.U. Virgen de la Arrixaca [06-016]
RECRUITINGMurcia, Spain
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ES-Salamanca-H.U. de Salamanca [06-021]
NOT_YET_RECRUITINGSalamanca, Spain
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IT-Ascoli Piceno-Ospedale Mazzoni [01-016]
RECRUITINGAscoli Piceno, Italy
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IT-Bari-A.O.U. Consorziale Policlinico - Medicina Interna [01-018]
NOT_YET_RECRUITINGBari, Italy
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IT-Bergamo-A.O. Papa Giovanni XXIII [01-003]
NOT_YET_RECRUITINGBergamo, Italy
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IT-Bologna-A.O.U. di Bologna - Policlinico S. Orsola Malpighi [01-004]
NOT_YET_RECRUITINGBologna, Italy
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IT-Bolzano-Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige [01-021]
NOT_YET_RECRUITINGBolzano, Italy
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IT-Como-Ospedale Classificato Valduce [01-104]
RECRUITINGComo, Italy
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IT-Milano-Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico [01-039]
NOT_YET_RECRUITINGMilan, Italy
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IT-Milano-Ospedale S. Carlo Borromeo [01-105]
RECRUITINGMilan, Italy
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IT-Novara-A.O.U. Maggiore della Carità [01-010]
RECRUITINGNovara, Italy
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IT-Pescara-Azienda USL di Pescara P.O. dello Spirito Santo [01-053]
RECRUITINGPescara, Italy
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IT-Roma-ASL Roma 1 [01-101]
NOT_YET_RECRUITINGRoma, Italy
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IT-Roma-Policlinico Umberto I - Università 'Sapienza' [01-013]
NOT_YET_RECRUITINGRoma, Italy
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IT-Torino-A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials [01-001]
NOT_YET_RECRUITINGTorino, Italy
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IT-Varese-Ospedale di Circolo [01-111]
NOT_YET_RECRUITINGVarese, Italy
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NL-Amsterdam-Vrije Universiteit Medical Center (VUMC) [02-007]
NOT_YET_RECRUITINGAmsterdam, Netherlands
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NL-Arnhem-Rijnstate Hospital [02-009]
NOT_YET_RECRUITINGArnhem, Netherlands
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NL-Den Haag-Haga Ziekenhuis [02-016]
NOT_YET_RECRUITINGThe Hague, Netherlands
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NL-Enschede-Medisch Spectrum Twente [02-024]
NOT_YET_RECRUITINGEnschede, Netherlands
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NL-Groningen-University Medical Center Groningen [02-030]
NOT_YET_RECRUITINGGroningen, Netherlands
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NL-Nieuwegein-S. Antonius Hospital [02-038]
NOT_YET_RECRUITINGNieuwegein, Netherlands
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NL-Schiedam-Franciscus Vlietland Hospital [02-049]
NOT_YET_RECRUITINGSchiedam, Netherlands
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NL-Sittard-Geleen-Zuyderland Medical Center [02-058]
NOT_YET_RECRUITINGSittard, Netherlands
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NL-Zwolle-Isala Klinieken [02-057]
NOT_YET_RECRUITINGZwolle, Netherlands
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NO-Oslo-Oslo University Hospital [23-007]
NOT_YET_RECRUITINGOslo, Norway
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NO-Tønsberg-Vestfold Hospital Trust [23-012]
NOT_YET_RECRUITINGTønsberg, Norway
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple-Drug combo aims to deepen myeloma response before transplant
- Cell therapy targets a marker on myeloma cells
- Oral drug combo targets myeloma that escaped the bone marrow
- Can a Four-Drug combo tame Ultra-High-Risk myeloma?
- MRI scans may reveal hidden clues to myeloma relapse risk
- Can a dual immunotherapy erase hidden myeloma cells?