Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088855
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2004-08-04
Brief Title:
Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Bortezomib PS-341 and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-09
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 the side effects and how well bortezomib and pegylated liposomal doxorubicin hydrochloride work in treating patients multiple myeloma that are experiencing symptoms and have not received prior treatment Bortezomib and pegylated liposomal doxorubicin hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the complete response CR near-complete response nCR rate of the bortezomibpegylated liposomal doxorubicin pegylated liposomal doxorubicin hydrochloride regimen in patients with previously untreated symptomatic multiple myeloma
II To evaluate the toxicity of the bortezomibpegylated liposomal doxorubicin regimen in patients with previously untreated symptomatic multiple myeloma
SECONDARY OBJECTIVES
I To evaluate the overall response rate including patients with CR nCR and partial response PR of the bortezomibpegylated liposomal doxorubicin regimen in patients with previously untreated symptomatic multiple myeloma
II To evaluate the impact of therapy with the bortezomibpegylated liposomal doxorubicin regimen on the ability to collect peripheral blood stem cells in those patients going on to subsequent autologous stem cell transplantation
III To evaluate the time to progression TTP in all patients receiving bortezomibpegylated liposomal doxorubicin therapy both those who go on to autologous stem cell transplantation and those who do not go on to transplantation
IV To evaluate the value of early changes in levels of serum interleukin 6 IL-6 and macrophage inflammatory protein 1 alpha MIP-1α as predictors of response to bortezomibpegylated liposomal doxorubicin
V To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity
OUTLINE
Patients receive bortezomib intravenously IV over 3-5 seconds on days 1 4 8 and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 weeks for 2 years and then every 6 months for 3 years
I To evaluate the complete response CR near-complete response nCR rate of the bortezomibpegylated liposomal doxorubicin pegylated liposomal doxorubicin hydrochloride regimen in patients with previously untreated symptomatic multiple myeloma
II To evaluate the toxicity of the bortezomibpegylated liposomal doxorubicin regimen in patients with previously untreated symptomatic multiple myeloma
SECONDARY OBJECTIVES
I To evaluate the overall response rate including patients with CR nCR and partial response PR of the bortezomibpegylated liposomal doxorubicin regimen in patients with previously untreated symptomatic multiple myeloma
II To evaluate the impact of therapy with the bortezomibpegylated liposomal doxorubicin regimen on the ability to collect peripheral blood stem cells in those patients going on to subsequent autologous stem cell transplantation
III To evaluate the time to progression TTP in all patients receiving bortezomibpegylated liposomal doxorubicin therapy both those who go on to autologous stem cell transplantation and those who do not go on to transplantation
IV To evaluate the value of early changes in levels of serum interleukin 6 IL-6 and macrophage inflammatory protein 1 alpha MIP-1α as predictors of response to bortezomibpegylated liposomal doxorubicin
V To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity
OUTLINE
Patients receive bortezomib intravenously IV over 3-5 seconds on days 1 4 8 and 11 and pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 4 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 weeks for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| NCI-2014-01607 | REGISTRY | None | None |
| NCI-2012-02810 | None | None | None |
| CDR377483 | None | None | None |
| CALGB 10301 | OTHER | None | None |
| CALGB-10301 | OTHER | None | None |
| U10CA180821 | NIH | None | None |
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |