Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003146
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Thiotepa Busulfan and Melphalan Followed by Autologous or Syngeneic Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES I Assess the toxicity and efficacy at the maximum tolerated dose of busulfan melphalan and thiotepa in patients with multiple myeloma
OUTLINE This is a single arm open label study Peripheral blood stem cells PBSC are collected and cryopreserved or bone marrow is harvested and stored until infusion on day 0 Patients receive oral busulfan every 6 hours on days -8 -7 and -6 Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4 Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2 Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy day 0 Patients are followed for 100 days posttransplant and every 3 months thereafter
PROJECTED ACCRUAL 30 patients will be accrued
OUTLINE This is a single arm open label study Peripheral blood stem cells PBSC are collected and cryopreserved or bone marrow is harvested and stored until infusion on day 0 Patients receive oral busulfan every 6 hours on days -8 -7 and -6 Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4 Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2 Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy day 0 Patients are followed for 100 days posttransplant and every 3 months thereafter
PROJECTED ACCRUAL 30 patients will be accrued
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065929 | REGISTRY | PDQ | None |
| FHCRC-120400 | None | None | None |
| NCI-H97-0007 | None | None | None |