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: Recruiting Phase 2 study of Multiple Myeloma, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For the primary objective "for all patients" to describe the depth of response obtained with 6 cycles of Dara-VRd and the corresponding endpoint of MRD negativity at end of induction all patients with MRD evaluable
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 |
What NCT05231629 shows while recruiting
NCT05231629 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (45% lower).
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 lists 10 locations in 9 states (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.
Where NCT05231629's enrollment target sits among peer trials
300 75th of 438 higher than 361 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
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI