Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112827
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2005-06-02
Brief Title:
Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I Stage II or Stage III Multiple Myeloma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Tandem High-Dose Therapy With Melphalan and Total Marrow Irradiation TMI With Peripheral Blood Progenitor Cell Support and Lenalidomide Maintenance in Multiple Myeloma A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2019-11
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 Melphalan a chemotherapeutic agent has been found to be an effective treatment choice for destroying myeloma cells especially when given at high bone marrow ablative doses Total marrow irradiation TMIablative dose radiation therapy is another modality capable of destroying myeloma cells Autologous peripheral bloodstem cell transplant ASCT given after either melphalan or following TMI aimed at the bone marrow containing areas of the skeleton the site of origin of myeloma cells will shorten the durationalleviate the severity of both melphalan and marrow irradiation-associated side effects Lenalidomide an effective agent on its own right for the treatment of myeloma has been shown to further enhance the beneficial effects of autologous stem cell transplants when given as maintenance therapy
PURPOSE This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT followed by TMI and a second ASCT with subsequent maintenance lenalidomide The study is conducted in patients with stages I-III myeloma with specific emphasis on assessing complete and very good partial response rate conversions progression-free and overall survival and safetyfeasibility of delivering the planned treatment regimen
PURPOSE This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT followed by TMI and a second ASCT with subsequent maintenance lenalidomide The study is conducted in patients with stages I-III myeloma with specific emphasis on assessing complete and very good partial response rate conversions progression-free and overall survival and safetyfeasibility of delivering the planned treatment regimen
Detailed Description:
PRIMARY OBJECTIVES
I To assess the feasibility and toxicities of tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of fractionated total marrow irradiation TMI using helical tomotherapy in patients with advanced multiple myeloma
II To establish the maximum tolerated dose of TMI using helical tomotherapy III To assess response rate progression free and over-all survival following treatment with tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of TMI using helical tomotherapy with DexamethasoneThalidomide maintenance therapy in patients with advanced multiple myeloma
IV To assess the feasibility of adding decadron and thalidomide as maintenance following the second cycle of high-dose therapy
SECONDARY OBJECTIVES
I To perform cytogenetic gene rearrangement and fluorescence in situ hybridization FISH studies on baseline and post-treatment bone marrow and blood specimens and correlate the presencepersistence of these features with treatment outcome
II To bankdevelop cell lines developed for future investigations of tumor biology and for potential assessment of efficacy of novel therapeutic agents
OUTLINE This is a dose-escalation study of total marrow irradiation TMI
PRIMING AND APHERESIS Patients receive cyclophosphamide IV over 2 hours Patients also receive filgrastim IV or subcutaneously daily beginning 24 hours after the administration of cyclophosphamide and continuing until apheresis is complete Patients undergo apheresis until an adequate number of peripheral blood stem cells are collected
ABLATIVE THERAPY
Course 1 Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 Patients then undergo autologous PBSC transplantation on day 0 and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover
Course 2 Beginning 6-18 weeks later patients undergo TMI once or twice daily on days -4 to -1 Patients then undergo autologous peripheral blood stem cell transplant and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover
MAINTENANCE THERAPY Beginning within 6-8 weeks of day 0 of course 2 TMI patients receive oral lenalidomide daily Courses repeat every 28 days for approximately 3 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days every 6 months for 1 year and then annually for at least 2 years
I To assess the feasibility and toxicities of tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of fractionated total marrow irradiation TMI using helical tomotherapy in patients with advanced multiple myeloma
II To establish the maximum tolerated dose of TMI using helical tomotherapy III To assess response rate progression free and over-all survival following treatment with tandem cycle ablative therapy consisting first of high-dose melphalan and then escalating doses of TMI using helical tomotherapy with DexamethasoneThalidomide maintenance therapy in patients with advanced multiple myeloma
IV To assess the feasibility of adding decadron and thalidomide as maintenance following the second cycle of high-dose therapy
SECONDARY OBJECTIVES
I To perform cytogenetic gene rearrangement and fluorescence in situ hybridization FISH studies on baseline and post-treatment bone marrow and blood specimens and correlate the presencepersistence of these features with treatment outcome
II To bankdevelop cell lines developed for future investigations of tumor biology and for potential assessment of efficacy of novel therapeutic agents
OUTLINE This is a dose-escalation study of total marrow irradiation TMI
PRIMING AND APHERESIS Patients receive cyclophosphamide IV over 2 hours Patients also receive filgrastim IV or subcutaneously daily beginning 24 hours after the administration of cyclophosphamide and continuing until apheresis is complete Patients undergo apheresis until an adequate number of peripheral blood stem cells are collected
ABLATIVE THERAPY
Course 1 Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 Patients then undergo autologous PBSC transplantation on day 0 and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover
Course 2 Beginning 6-18 weeks later patients undergo TMI once or twice daily on days -4 to -1 Patients then undergo autologous peripheral blood stem cell transplant and receive filgrastim IV or subcutaneously beginning on day 5 and continuing until blood counts recover
MAINTENANCE THERAPY Beginning within 6-8 weeks of day 0 of course 2 TMI patients receive oral lenalidomide daily Courses repeat every 28 days for approximately 3 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days every 6 months for 1 year and then annually for at least 2 years
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 |
|---|---|---|---|
| CDR0000428410 | OTHER | NCI PDQ | None |
| NCI-2009-01601 | None | None | None |