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Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

NCT06353022 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-03-17

No results posted yet for this study

Summary

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).

The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.

Conditions

Interventions

DRUG

Teclistamab

Maintenance therapy wtih teclistamab (administered via SC injections) for finite duration. Teclistamab will be used in 28 day cycles following initial step up doses

DRUG

Talquetamab

Maintenance therapy with talquetamab (administered via SC injections) for finite duration. Talquetamab will be used in 28 day cycles following initial step up doses

DRUG

Lenalidomide

Induction therapy with lenalidomide: Lenalidomide 25 mg/day oral from Day 1 to Day 21. Maintenance therapy lenalidomide (administered orally) for finite duration.

DRUG

Bortezomib

Induction therapy with Borthezomib Cycle 1 to 6: Bortezomib 1.3 mg/m² SC twice a week on Days 1, 4, 8 and 11

DRUG

Daratumumab

Induction therapy with Daratumumab Cycle 1 to 6 Daratumumab 1800 mg SC on Days 1, 8, 15, 22 of Cycle 1 and Cycle 2 and on Days 1 and 15 of Cycle 3

DRUG

Dexamethasone

Induction therapy with Dexamethasone: cycle 1 to 3 Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22 Cycle 4 to 6 --\> Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22

Sponsors & Collaborators

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2028-04-26
Completion
2030-06-26

Countries

  • France

Study Locations

More Related Trials

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 NCT06353022 on ClinicalTrials.gov