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

NCT07107529 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-15

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • EMN Trial Office S.r.l. Impresa Sociale

    collaborator OTHER

  • HOVON - Dutch Haemato-Oncology Association

    collaborator OTHER

  • PETHEMA Foundation

    collaborator OTHER

  • Nordic Myeloma Study Group

    collaborator OTHER

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • European Myeloma Network B.V.

    lead NETWORK

Principal Investigators

  • Sonja Zweegman · Vrije Universiteit Medical Center (VUMC)

  • Maria-Victoria Mateos · University of Salamanca

  • Fredrik Schjesvold · Oslo University Hospital

  • Alessandra Larocca · A.O.U. Città della Salute e della Scienza di Torino

  • Niels van de Donk · Vrije Universiteit Medical Center (VUMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2029-04-30
Completion
2034-02-28

Countries

  • Italy
  • Netherlands
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107529 on ClinicalTrials.gov