Actively Recruiting
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Led by European Myeloma Network B.V. · Updated on 2026-04-15
150
Participants Needed
29
Research Sites
424 weeks
Total Duration
On this page
Sponsors
E
European Myeloma Network B.V.
Lead Sponsor
E
EMN Trial Office S.r.l. Impresa Sociale
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older and capable of giving informed consent
- Newly diagnosed and treatment-naive with confirmed multiple myeloma and measurable disease per IMWG criteria
- Measurable disease defined as M-protein in serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL with abnormal kappa/lambda ratio
- Frail according to the Simplified IMWG frailty index
- Clinical laboratory values within defined ranges
- Patients of childbearing potential agree to use highly effective contraception from consent until 3 months after last study drug dose
You will not qualify if you...
- Non-secretory multiple myeloma or measurable disease only by urine or plasmacytoma
- Central nervous system involvement of myeloma
- Significant lung dysfunction
- Stroke, transient ischemic attack, or seizure within 6 months prior
- Active systemic viral, fungal, or bacterial infections requiring systemic treatment
- HIV or hepatitis infections
- History of other malignancies at high risk of recurrence requiring treatment or treated with chemotherapy affecting bone marrow capacity
- Any active malignancy other than multiple myeloma requiring treatment change in last 24 months
- Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months
- Life-threatening allergies or intolerance to study treatments
- Extensive radiotherapy within 14 days or focal radiation within 7 days
- Current or recent multiple myeloma therapy or corticosteroids >40 mg dexamethasone equivalent within 14 days
- Received live attenuated vaccine within 4 weeks prior
- Use of strong CYP3A4 inducers or St. John's wort within 5 half-lives prior
- Major surgery or significant trauma within 2 weeks prior (except kyphoplasty or vertebroplasty)
- Received investigational drugs or invasive devices within 4 weeks prior except long-term survival data collection
- Medical or psychiatric conditions interfering with study participation or safety
- Any other condition that would impair ability to receive treatment, understand consent, or complete assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
IT-Ascoli Piceno-Ospedale Mazzoni [01-016]
Ascoli Piceno, Italy
Actively Recruiting
2
IT-Bari-A.O.U. Consorziale Policlinico - Medicina Interna [01-018]
Bari, Italy
Not Yet Recruiting
3
IT-Bergamo-A.O. Papa Giovanni XXIII [01-003]
Bergamo, Italy
Not Yet Recruiting
4
IT-Bologna-A.O.U. di Bologna - Policlinico S. Orsola Malpighi [01-004]
Bologna, Italy
Not Yet Recruiting
5
IT-Bolzano-Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige [01-021]
Bolzano, Italy
Not Yet Recruiting
6
IT-Como-Ospedale Classificato Valduce [01-104]
Como, Italy
Actively Recruiting
7
IT-Milano-Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico [01-039]
Milan, Italy
Not Yet Recruiting
8
IT-Milano-Ospedale S. Carlo Borromeo [01-105]
Milan, Italy
Actively Recruiting
9
IT-Novara-A.O.U. Maggiore della Carità [01-010]
Novara, Italy
Actively Recruiting
10
IT-Pescara-Azienda USL di Pescara P.O. dello Spirito Santo [01-053]
Pescara, Italy
Actively Recruiting
11
IT-Roma-ASL Roma 1 [01-101]
Roma, Italy
Not Yet Recruiting
12
IT-Roma-Policlinico Umberto I - Università 'Sapienza' [01-013]
Roma, Italy
Not Yet Recruiting
13
IT-Torino-A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials [01-001]
Torino, Italy
Not Yet Recruiting
14
IT-Varese-Ospedale di Circolo [01-111]
Varese, Italy
Not Yet Recruiting
15
NL-Amsterdam-Vrije Universiteit Medical Center (VUMC) [02-007]
Amsterdam, Netherlands
Not Yet Recruiting
16
NL-Arnhem-Rijnstate Hospital [02-009]
Arnhem, Netherlands
Not Yet Recruiting
17
NL-Enschede-Medisch Spectrum Twente [02-024]
Enschede, Netherlands
Not Yet Recruiting
18
NL-Groningen-University Medical Center Groningen [02-030]
Groningen, Netherlands
Not Yet Recruiting
19
NL-Nieuwegein-S. Antonius Hospital [02-038]
Nieuwegein, Netherlands
Not Yet Recruiting
20
NL-Schiedam-Franciscus Vlietland Hospital [02-049]
Schiedam, Netherlands
Not Yet Recruiting
21
NL-Sittard-Geleen-Zuyderland Medical Center [02-058]
Sittard, Netherlands
Not Yet Recruiting
22
NL-Den Haag-Haga Ziekenhuis [02-016]
The Hague, Netherlands
Not Yet Recruiting
23
NL-Zwolle-Isala Klinieken [02-057]
Zwolle, Netherlands
Not Yet Recruiting
24
NO-Oslo-Oslo University Hospital [23-007]
Oslo, Norway
Not Yet Recruiting
25
NO-Tønsberg-Vestfold Hospital Trust [23-012]
Tønsberg, Norway
Not Yet Recruiting
26
ES-Barcelona-H.U. Vall d'Hebrón [06-002]
Barcelona, Spain
Not Yet Recruiting
27
ES-Las Palmas-H.U. de Gran Canaria Dr Negrín [06-030]
Las Palmas, Spain
Not Yet Recruiting
28
ES-Murcia-H.U. Virgen de la Arrixaca [06-016]
Murcia, Spain
Actively Recruiting
29
ES-Salamanca-H.U. de Salamanca [06-021]
Salamanca, Spain
Not Yet Recruiting
Research Team
C
Clinical Trial Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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