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NCT05243797 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

A Phase 3 study of Multiple Myeloma, sponsored by European Myeloma Network B.V..

Recruiting
Registry status
Phase 3
Development phase
1,594
Enrollment target
20
Study locations

NCT05243797: Recruiting Phase 3 study of Multiple Myeloma, sponsored by European Myeloma Network B.V..

NCT05243797 is a Phase 3 study of Multiple Myeloma that is actively recruiting participants, run by European Myeloma Network B.V.. The registered enrollment target is 1,594 participants, above the 543-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (194% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05243797, a Phase 3 study of Multiple Myeloma, is actively recruiting participants, sponsored by European Myeloma Network B.V..

RECRUITING
Registry status
Phase 3
Development phase
1,594 participants
Enrollment target
20
Study locations

Study Summary

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Primary Outcome

PFS is defined as the time from the date of randomization to the date of disease progression (as assessed by IMWG criteria) or death due to any cause, whichever occurs first.

Conditions Studied

Interventions

  • DRUG Teclistamab
  • DRUG Lenalidomide

Study Locations (20)

California

  • UCLA Medical Center - Los Angeles
  • University of California-Davis Cancer Center - Sacramento
  • University of California, San Diego (UCSD) Medical Center - San Diego

Colorado

  • University of Colorado Hospital - Aurora
  • Colorado Blood Cancer Institute - Denver

Florida

  • Blood & Marrow Transplant Center, Florida Hospital Medical Group - Orlando
  • Moffitt at Memorial Healthcare System - Tampa

Maryland

  • Greenebaum Cancer Center UM of MD - Baltimore
  • John Hopkins - Baltimore

Massachusetts

  • Tufts Medical Center - Boston
  • Beth Israel Deaconess Medical Center - Boston

New York

  • Mount Sinai Medical Center - 2 - New York
  • Montefiore Medical Cente - The Bronx

Arizona

  • Banner University Medical Center Tucson, University of Arizona - Phoenix

Connecticut

  • Yale New Haven Hospital - New Haven

Trial Details

FieldValue
Enrollment Target 1,594 participants
Start Date 2022-09-08
Est. Completion 2032-04
Phase Phase 3
European Myeloma Network B.V.

1 total trials

What NCT05243797 shows while recruiting

NCT05243797 is an interventional study that assigns participants to a tested intervention. Its 1,594 participants enrollment target places it among the larger protocols in the corpus, above the 543-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (194% higher).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Teclistamab is the first listed.

NCT05243797 names 20 study sites across 13 states, led by California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT05243797 about?

NCT05243797 is a clinical study titled "Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation". This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

What is the current status of trial NCT05243797?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,594 participants. The study started on 2022-09-08. Estimated completion is 2032-04.

What conditions does trial NCT05243797 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT05243797?

The interventions under investigation include: Teclistamab (DRUG), Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT05243797?

This trial is sponsored by European Myeloma Network B.V., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05243797 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05243797's enrollment target sits among peer trials

1,594 15th of 438 higher than 424 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05243797, the US trial registry maintained by the National Library of Medicine. NCT05243797 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.