Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01163357 · ClinicalTrials.gov registry record · Phase 1
Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma
A Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01163357 is a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that has completed, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01163357, a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation in treating patients undergoing donor peripheral blood stem cell transplant for high-risk stage I or II multiple myeloma.
Conditions Studied
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG bortezomib
- RADIATION total marrow irradiation
- OTHER melphalan
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-01-28 |
| Est. Completion | 2024-05-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01163357
The ClinicalTrials.gov registry entry for NCT01163357 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (61% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT01163357 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01163357 about?
NCT01163357 is a clinical study titled "Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma". RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer ...
What is the current status of trial NCT01163357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-01-28. Estimated completion is 2024-05-20.
What conditions does trial NCT01163357 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Plasma Cell Leukemia, Autologous Hematopoietic Stem Cell Transplant Recipient, Loss of Chromosome 17p.
What interventions are being tested in trial NCT01163357?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), bortezomib (DRUG), total marrow irradiation (RADIATION), melphalan (OTHER).
Who is sponsoring clinical trial NCT01163357?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01163357 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell 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.
-
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
RECRUITING · Phase 1
-
CS1-CAR T Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory CS1 Positive Multiple Myeloma
RECRUITING · Phase 1
-
Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma
ACTIVE NOT RECRUITING · Phase 1
-
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
ACTIVE NOT RECRUITING · Phase 1
-
Genetically Engineered Cells (MUC1-Activated T-Cells) for the Treatment of MUC1 Positive Recurrent or Refractory Multiple Myeloma
ACTIVE NOT RECRUITING · Phase 1
-
Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma
ACTIVE NOT RECRUITING · Phase 1
Explore more on PlainTrial
Refractory Plasma Cell Myeloma
All registered trials for this condition
Recurrent Plasma Cell Myeloma
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
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.