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Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

NCT05572229 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-09-17

No results posted yet for this study

Summary

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients

This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Conditions

Interventions

DRUG

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

DRUG

Daratumumab

Daratumumab will be administered via a subcutaneous injection (SC)

DRUG

Lenalidomide

Lenalidomide will be administered orally

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Salomon MANIER, MD · University Hospital, Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2026-04-30
Completion
2030-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT05572229 on ClinicalTrials.gov