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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. (NCT07107529) is a Phase 2 interventional studying Multiple Myeloma (MM), sponsored by European Myeloma Network B.V.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab. The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma (MM) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma (MM) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient is ≥18 years of age and capable of giving willing to sign a consent form and must sign an willing to sign a consent form 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 willing to sign a consent form form through 3 months after the last dose of study drug Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body) requiring systemic immunosuppressive therapy within 6 months before eligibility ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

DRUG

Talquetamab

Talquetamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

DRUG

Daratumumab

Dartumumab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

IT-Ascoli Piceno-Ospedale Mazzoni [01-016]
Ascoli Piceno, Italy
IT-Bari-A.O.U. Consorziale Policlinico - Medicina Interna [01-018]
Bari, Italy
IT-Bergamo-A.O. Papa Giovanni XXIII [01-003]
Bergamo, Italy
IT-Bologna-A.O.U. di Bologna - Policlinico S. Orsola Malpighi [01-004]
Bologna, Italy
IT-Bolzano-Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige [01-021]
Bolzano, Italy
IT-Como-Ospedale Classificato Valduce [01-104]
Como, Italy
IT-Milano-Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico [01-039]
Milan, Italy
IT-Milano-Ospedale S. Carlo Borromeo [01-105]
Milan, Italy
IT-Novara-A.O.U. Maggiore della Carità [01-010]
Novara, Italy
IT-Pescara-Azienda USL di Pescara P.O. dello Spirito Santo [01-053]
Pescara, Italy
IT-Roma-ASL Roma 1 [01-101]
Roma, Italy
IT-Roma-Policlinico Umberto I - Università 'Sapienza' [01-013]
Roma, Italy
IT-Torino-A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials [01-001]
Torino, Italy
IT-Varese-Ospedale di Circolo [01-111]
Varese, Italy
NL-Amsterdam-Vrije Universiteit Medical Center (VUMC) [02-007]
Amsterdam, Netherlands
NL-Arnhem-Rijnstate Hospital [02-009]
Arnhem, Netherlands
NL-Enschede-Medisch Spectrum Twente [02-024]
Enschede, Netherlands
NL-Groningen-University Medical Center Groningen [02-030]
Groningen, Netherlands
NL-Nieuwegein-S. Antonius Hospital [02-038]
Nieuwegein, Netherlands
NL-Schiedam-Franciscus Vlietland Hospital [02-049]
Schiedam, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07107529), the sponsor (European Myeloma Network B.V.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07107529 clinical trial studying?

This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab. The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07107529?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07107529?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07107529. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07107529. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.