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

NCT07107529 | Recruiting Phase 2 DMC

• 2 other identifiers: EMN372024-520433-76-00
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 29

Brief Summary

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

Multiple Myeloma (MM)

Keywords

Newly diagnosed multiple myeloma (NDMM); Frail patient; Talquetamab; Teclistamab

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per IMWG criteria

  defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.

  18 months

Secondary Outcomes (21)

• Overall Survival (OS)

  9 years

• Minimal Residual Disease (MRD) negativity rate

  18 months

• Minimal Residual Disease (MRD) negative CR

  18 months

• Sustained Minimal Residual Disease (MRD) negative CR

  9 years

• IMWG best response

  18 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Tec-Dara

Drug: Teclistamab; Drug: Daratumumab

Cohort 2

EXPERIMENTAL

Tal-Dara

Drug: Talquetamab; Drug: Daratumumab

Interventions

Teclistamab DRUG

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

Cohort 1

Talquetamab DRUG

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

Cohort 2

Daratumumab DRUG

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-secretory MM or measurable disease by urine or plasmacytoma only
• Central nervous system involvement of myeloma
• Significant pulmonary dysfunction
• 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.
• Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)
• 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

Sponsors & Collaborators

• European Myeloma Network B.V.: lead
• EMN Trial Office S.r.l. Impresa Sociale: collaborator
• HOVON - Dutch Haemato-Oncology Association: collaborator
• PETHEMA Foundation: collaborator
• Nordic Myeloma Study Group: collaborator
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (29)

IT-Ascoli Piceno-Ospedale Mazzoni [01-016]

Ascoli Piceno, Italy

RECRUITING

IT-Bari-A.O.U. Consorziale Policlinico - Medicina Interna [01-018]

Bari, Italy

NOT YET RECRUITING

IT-Bergamo-A.O. Papa Giovanni XXIII [01-003]

Bergamo, Italy

NOT YET RECRUITING

IT-Bologna-A.O.U. di Bologna - Policlinico S. Orsola Malpighi [01-004]

Bologna, Italy

NOT YET RECRUITING

IT-Bolzano-Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige [01-021]

Bolzano, Italy

NOT YET RECRUITING

IT-Como-Ospedale Classificato Valduce [01-104]

Como, Italy

RECRUITING

IT-Milano-Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico [01-039]

Milan, Italy

NOT YET RECRUITING

IT-Milano-Ospedale S. Carlo Borromeo [01-105]

Milan, Italy

RECRUITING

IT-Novara-A.O.U. Maggiore della Carità [01-010]

Novara, Italy

RECRUITING

IT-Pescara-Azienda USL di Pescara P.O. dello Spirito Santo [01-053]

Pescara, Italy

RECRUITING

IT-Roma-ASL Roma 1 [01-101]

Roma, Italy

NOT YET RECRUITING

IT-Roma-Policlinico Umberto I - Università 'Sapienza' [01-013]

Roma, Italy

NOT YET RECRUITING

IT-Torino-A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials [01-001]

Torino, Italy

NOT YET RECRUITING

IT-Varese-Ospedale di Circolo [01-111]

Varese, Italy

NOT YET RECRUITING

NL-Amsterdam-Vrije Universiteit Medical Center (VUMC) [02-007]

Amsterdam, Netherlands

NOT YET RECRUITING

NL-Arnhem-Rijnstate Hospital [02-009]

Arnhem, Netherlands

NOT YET RECRUITING

NL-Enschede-Medisch Spectrum Twente [02-024]

Enschede, Netherlands

NOT YET RECRUITING

NL-Groningen-University Medical Center Groningen [02-030]

Groningen, Netherlands

NOT YET RECRUITING

NL-Nieuwegein-S. Antonius Hospital [02-038]

Nieuwegein, Netherlands

NOT YET RECRUITING

NL-Schiedam-Franciscus Vlietland Hospital [02-049]

Schiedam, Netherlands

NOT YET RECRUITING

NL-Sittard-Geleen-Zuyderland Medical Center [02-058]

Sittard, Netherlands

NOT YET RECRUITING

NL-Den Haag-Haga Ziekenhuis [02-016]

The Hague, Netherlands

NOT YET RECRUITING

NL-Zwolle-Isala Klinieken [02-057]

Zwolle, Netherlands

NOT YET RECRUITING

NO-Oslo-Oslo University Hospital [23-007]

Oslo, Norway

NOT YET RECRUITING

NO-Tønsberg-Vestfold Hospital Trust [23-012]

Tønsberg, Norway

NOT YET RECRUITING

ES-Barcelona-H.U. Vall d'Hebrón [06-002]

Barcelona, Spain

NOT YET RECRUITING

ES-Las Palmas-H.U. de Gran Canaria Dr Negrín [06-030]

Las Palmas, Spain

NOT YET RECRUITING

ES-Murcia-H.U. Virgen de la Arrixaca [06-016]

Murcia, Spain

RECRUITING

ES-Salamanca-H.U. de Salamanca [06-021]

Salamanca, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sonja Zweegman

  Vrije Universiteit Medical Center (VUMC)

  PRINCIPAL INVESTIGATOR

• Maria-Victoria Mateos

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Fredrik Schjesvold

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Alessandra Larocca

  A.O.U. Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

• Niels van de Donk

  Vrije Universiteit Medical Center (VUMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Office

CONTACT

+390110243236; amministrazione@emnresearch.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): February 1, 2034
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (9); IT (14); ES (4); NO (2)