Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00088855|
Recruitment Status : Active, not recruiting
First Posted : August 5, 2004
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma||Drug: Bortezomib Other: Laboratory Biomarker Analysis Drug: Pegylated Liposomal Doxorubicin Hydrochloride||Phase 2|
I. To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
I. To evaluate the overall response rate, including patients with CR, nCR, and partial response (PR), of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
II. To evaluate the impact of therapy with the bortezomib/pegylated 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 bortezomib/pegylated 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 bortezomib/pegylated liposomal doxorubicin.
V. To correlate pre-treatment clinical and biological characteristics with response to therapy and toxicity.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bortezomib (PS-341) and Pegylated Liposomal Doxorubicin as Initial Therapy for Adult Patients With Symptomatic Multiple Myeloma|
|Actual Study Start Date :||June 15, 2004|
|Actual Primary Completion Date :||October 31, 2006|
Experimental: Treatment (bortezomib and pegylated liposomal doxorubicin)
Patients receive bortezomib 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.
Other: Laboratory Biomarker Analysis
Drug: Pegylated Liposomal Doxorubicin Hydrochloride
- CR+nCR rate [ Time Frame: After 18 weeks (6 courses of treatment) ]Will be estimated with an exact 90% confidence interval.
- CR+nCR+PR rate [ Time Frame: After 18 weeks (6 courses of treatment) ]Will be estimated with an exact 90% confidence interval.
- Maximal response rate [ Time Frame: After 18 weeks (6 courses of treatment) ]
- Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]Toxicities will be tabulated by type and grade.
- Progression-free survival [ Time Frame: From on-study date to the date of progression or death, whichever comes first, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: From on-study date to the date of death, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- Changes in IL-6 and MIP-1 [ Time Frame: Baseline to up to day 2 of course 1 ]The association of response with pre-treatment characteristics such as cytogenetics and fluorescence in situ hybridization and with early changes in IL-6 and MIP-1 will be described by reporting response rates (and their confidence intervals) according to subgroup (e.g., response rates by age group; response rates by large/small change in IL-6 level).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088855
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|Principal Investigator:||Robert Orlowski||Alliance for Clinical Trials in Oncology|