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NCT04140162 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

A Phase 2 study of Multiple Myeloma, sponsored by University of Michigan Rogel Cancer Center.

Active
Registry status
Phase 2
Development phase
57
Enrollment target
4
Study locations

NCT04140162 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 57 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT04140162, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
57 participants
Enrollment target
4
Study locations

Study Summary

This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Daratumumab
  • DRUG Bortezomib

Study Locations (4)

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor
  • Barbara Ann Karmanos Cancer Institute - Detroit

New York

  • University of Rochester - Rochester

Texas

  • University of Texas Southwestern -- Simmons Comprehensive Cancer Center - Dallas

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2020-10-05
Est. Completion 2026-05-02
Phase Phase 2

What the Registry Record Tells You About NCT04140162

The ClinicalTrials.gov registry entry for NCT04140162 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.

NCT04140162 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Michigan, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT04140162 about?

NCT04140162 is a clinical study titled "Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy". This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disea...

What is the current status of trial NCT04140162?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2020-10-05. Estimated completion is 2026-05-02.

What conditions does trial NCT04140162 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT04140162?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT04140162?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04140162 being conducted?

This trial has 4 study locations across Michigan, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.