Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05231629 · ClinicalTrials.gov registry record · Phase 2
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
A Phase 2 study of Multiple Myeloma, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 10
- Study locations
NCT05231629 is a Phase 2 study of Multiple Myeloma that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 300 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT05231629, a Phase 2 study of Multiple Myeloma, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 10
- Study locations
Study Summary
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
Conditions Studied
Interventions
- DRUG Dara-VRd intensification, Dara-R maintenance
- DRUG AHCT intensification, Dara-R maintenance
- DRUG AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance
- DRUG AHCT intensification, Dara-R consolidation, Dara-R maintenance
- DRUG Dara-VRd induction
Study Locations (10)
Wisconsin
- University of Wisconsin - Carbone - Madison
- Medical College of Wisconsin - Milwaukee
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Colorado Blood Cancer Institute - Denver
New York
- Columbia University - New York
Oregon
- Oregon Health and Science University - Portland
Tennessee
- Vanderbilt University - Nashville
Texas
- University of Texas Southwestern - Dallas
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05231629
The ClinicalTrials.gov registry entry for NCT05231629 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dara-VRd intensification, Dara-R maintenance is the first listed.
NCT05231629 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Wisconsin, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT05231629 about?
NCT05231629 is a clinical study titled "Sequential Therapy in Multiple Myeloma Guided by MRD Assessments". This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patien...
What is the current status of trial NCT05231629?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-12-13. Estimated completion is 2027-12.
What conditions does trial NCT05231629 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT05231629?
The interventions under investigation include: Dara-VRd intensification, Dara-R maintenance (DRUG), AHCT intensification, Dara-R maintenance (DRUG), AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance (DRUG), AHCT intensification, Dara-R consolidation, Dara-R maintenance (DRUG), Dara-VRd induction (DRUG).
Who is sponsoring clinical trial NCT05231629?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05231629 being conducted?
This trial has 10 study locations across Alabama, Colorado, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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.
-
A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant
RECRUITING · Phase 2
-
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
RECRUITING · Phase 2
-
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
CAR T-cell Therapy in Patients With Renal Dysfunction
RECRUITING · Phase 2
-
IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
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.