A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dara-RVd — DRUG
  This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy
• Tec-RVd — DRUG
  This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy

Study Details

The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab, lenalidomide, bortezomib, and dexamethasone) is a safe treatment for people with newly diagnosed multiple myeloma (MM).

Key Dates

Start date

Jul 24, 2025

Status verified

Feb 2026

Primary completion

Jul 24, 2029

Completion

Jul 24, 2029

Study Design

Enrollment

65 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I
  The phase 1 part of the study evaluates the safety and toxicity of Tec-RVd
• Experimental: Phase II, Stage 1
  The phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy. If 4 or less participants achieve a MRD- after 6 cycles evaluation the trial will be stopped. If 5 or more participants accomplish a MRD- the trial will move on to stage 2
• Experimental: Phase II, Stage 2
  The phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy.

Primary Outcome Measure

Phase I: Toxicity [ Time Frame: up to 4 months ]

Central Contacts

• Neha Korde, MD
  646-608-3708
  [email protected]
• Carlyn Rose Tan, MD
  646-608-3778
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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