Tests teclistamab or talquetamab with daratumumab in frail myeloma patients
Tests two drug combinations in frail adults newly diagnosed with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Key facts
- Where
- Barcelona, Las Palmas De Gran Canaria, Murcia, and Salamanca, SpainSee the 4 sites
- Phase
- Phase 2
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran Canaria, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- European Myeloma Network B.V.
- Trial code
- NCT07107529EU 2024-520433-76-00
- Record updated
- 15 April 2026
- Original description
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.Read full original descriptionShow less
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
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).
Inclusion: 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; Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria; 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; Frail according to the Simplified IMWG frailty index; Have clinical laboratory values meeting defined range; 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: Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility; Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility; 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; Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed; Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing; Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery; 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; 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; Non-secretory MM or measurable disease by urine or plasmacytoma only; Stroke, transient ischemic attack, or seizure within 6 months of eligibility; Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy; HIV and Hepatitis infections; Exclude for any of the following:; 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; Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma; Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI); 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; Central nervous system involvement of myeloma; Significant pulmonary dysfunction.