Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05145400 · ClinicalTrials.gov registry record · Phase 2
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study of Cancer and Multiple Myeloma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT05145400: Recruiting Phase 2 study of Cancer and Multiple Myeloma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05145400 is a Phase 2 study of Cancer and Multiple Myeloma that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 50 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145400, a Phase 2 study of Cancer and Multiple Myeloma, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.
Primary Outcome
ORR, percentage of patients achieving a partial response or better per Revised Uniform Response Criteria by the International Myeloma Working Group (IMWG) criteria. Complete response (CR): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow (BM). Stringent complete response (sCR): CR plus normal free light chains (FLC) ratio and absence of clonal plasma cells in BM biopsy. Very good partial response (VGPR):-Serum and urine
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Isatuximab
Study Locations (5)
North Carolina
- University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center - Chapel Hill
- Levine Cancer Institute - Charlotte
- Duke Comprehensive Cancer Center - Durham
- Novant Health New Hanover Regional Medical Center - Wilmington
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2031-03-01 |
| Phase | Phase 2 |
What NCT05145400 shows while recruiting
NCT05145400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT05145400 lists 5 locations in 2 states (North Carolina, Ohio).
Frequently Asked Questions
What is clinical trial NCT05145400 about?
NCT05145400 is a clinical study titled "Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma". This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to...
What is the current status of trial NCT05145400?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-02-18. Estimated completion is 2031-03-01.
What conditions does trial NCT05145400 study?
This clinical trial studies the following conditions: Cancer, Multiple Myeloma.
What interventions are being tested in trial NCT05145400?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Isatuximab (DRUG).
Who is sponsoring clinical trial NCT05145400?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05145400 being conducted?
This trial has 5 study locations across North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
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 NCT05145400's enrollment target sits among peer trials
50 422nd of 615 higher than 179 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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
-
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
RECRUITING · Phase 2
-
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
RECRUITING · Phase 2
-
CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
RECRUITING · Phase 2
-
Acupuncture for People Experiencing Period Loss Due to Chemotherapy
RECRUITING · Phase 2
-
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
RECRUITING · Phase 2
-
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases
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
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
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