Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT01605032
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2012-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma
Sponsor:
Albert Einstein College of Medicine
Organization:
Study Overview
Official Title:
Phase II Study Assessing the Efficacy and Toxicity of PK--directed Intravenous Busulfan in Combination With High--Dose Melphalan and Bortezomib as Conditioning Regimen for First--Line Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy before a peripheral blood stem cell transplant may stop the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the complete response rate as defined by the International Myeloma Working Group (IMWG) criteria for patients with multiple myeloma treated with high dose chemotherapy with pharmacokinetic (PK) directed intravenous (IV) busulfan, bortezomib and melphalan (Bu/BTZ/Mel140) followed by autologous hematopoietic stem cell transplantation (ASCT) as first line therapy.
SECONDARY OBJECTIVES:
I. To determine the overall response rate of the regimen Bu/BTZ/Mel140. II. To determine the treatment related toxicity and mortality of the regimen, including 100-day mortality rates.
III. To determine the duration of response, time to progression, progression-free survival, event-free survival and overall survival for this conditioning regimen.
IV. To determine whether there is a gender or race difference in the pharmacokinetic profile of IV busulfan.
V. To determine methylation and gene expression signatures of pre-treatment bone marrow plasma cells and explore associations of these signatures with outcome.
OUTLINE:
CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.
TRANSPLANT: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0.
After completion of study treatment, patients are followed up for up to 5 years.
I. To determine the complete response rate as defined by the International Myeloma Working Group (IMWG) criteria for patients with multiple myeloma treated with high dose chemotherapy with pharmacokinetic (PK) directed intravenous (IV) busulfan, bortezomib and melphalan (Bu/BTZ/Mel140) followed by autologous hematopoietic stem cell transplantation (ASCT) as first line therapy.
SECONDARY OBJECTIVES:
I. To determine the overall response rate of the regimen Bu/BTZ/Mel140. II. To determine the treatment related toxicity and mortality of the regimen, including 100-day mortality rates.
III. To determine the duration of response, time to progression, progression-free survival, event-free survival and overall survival for this conditioning regimen.
IV. To determine whether there is a gender or race difference in the pharmacokinetic profile of IV busulfan.
V. To determine methylation and gene expression signatures of pre-treatment bone marrow plasma cells and explore associations of these signatures with outcome.
OUTLINE:
CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4.
TRANSPLANT: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0.
After completion of study treatment, patients are followed up for up to 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01207 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 11-102 | None | None | View | |
| 11-12-434 | OTHER | Albert Einstein College of Medicine | View | |
| P30CA013330 | NIH | None | https://reporter.nih.gov/quic… | View |