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Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

NCT05849610 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-11

No results posted yet for this study

Summary

The goal of this Phase 2, open-label, multicenter, non-randomized pilot study is to evaluate the efficacy (in terms of MRD negative CR rate after Intensification therapy) and safety of Tec-Dara (Teclistamab+Daratumumab) and Tal-Dara (Talquetamab+Daratumumab) in de novo high-risk multiple myeloma (DNHRMM) patients.

Conditions

  • High-Risk de Novo Multiple Myeloma

Interventions

DRUG

Daratumumab

Daratumumab will be administered by SC injection.

DRUG

Bortezomib

Bortezomib dose will be calculated using the patient's actual body surface area (BSA) at baseline and will be administered by subcutaneous (SC) injection.

DRUG

Lenalidomide

Lenalidomide will be administered by oral route.

DRUG

Teclistamab

Teclistamab will be administered by SC injection.

DRUG

Talquetamab

Talquetamab will be administered by subcutaneous (SC) injection.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Juan José Lahuerta Palacios, Dr · Hospital Universitario 12 de Octubre

  • Joan Bladé, Dr · Hospital Clinic of Barcelona

  • Mª Victoria Mateos, Dr · Hospital Clínico Universitario de Salamanca

  • Paula Rodríguez Otero, Dr · Clínica Universidad de Navarra

  • Jesús San Miguel, Dr · Clínica Universidad de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2026-03-03
Completion
2029-07-31

Countries

  • 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 NCT05849610 on ClinicalTrials.gov