Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00997386 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
A Phase 2 study of Multiple Myeloma and Myelofibrosis, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00997386: Completed Phase 2 study of Multiple Myeloma and Myelofibrosis, sponsored by University of Arizona.
NCT00997386 is a Phase 2 study of Multiple Myeloma and Myelofibrosis that has completed, run by University of Arizona. The registered enrollment target is 16 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00997386, a Phase 2 study of Multiple Myeloma and Myelofibrosis, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.
Primary Outcome
To determine the efficacy of related or unrelated allogeneic PBSC transplantation (PBSCT) using a preparative regimen of busulfan, melphalan and alemtuzumab, as measured by durable donor lymphohematopoietic cell engraftment. The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).
Conditions Studied
Interventions
- DRUG busulfan, and melphalan, and alemtuzumab
Study Locations (1)
Arizona
- University Medical Center and UMC-North Clinic - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT00997386 record still lists
NCT00997386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which busulfan, and melphalan, and alemtuzumab is the first listed.
NCT00997386 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT00997386 about?
NCT00997386 is a clinical study titled "Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States". The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold...
What is the current status of trial NCT00997386?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-09. Estimated completion is 2016-01.
What conditions does trial NCT00997386 study?
This clinical trial studies the following conditions: Multiple Myeloma, Myelofibrosis, Hematologic Neoplasms, Anemia, Aplastic, Hemoglobinuria, Paroxysmal.
What interventions are being tested in trial NCT00997386?
The interventions under investigation include: busulfan, and melphalan, and alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT00997386?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00997386 being conducted?
This trial has 1 study location across Arizona. 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 NCT00997386's enrollment target sits among peer trials
16 404th of 438 higher than 32 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
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia