- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00706953
A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib
A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to evaluate the overall response rate to DOXIL/VELCADE treatment in patients with relapsed multiple myeloma previously treated with VELCADE. Overall response rate is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) to treatment according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. This is a single arm (all patients will receive the same drug combination and dose), multi-center (many study sites), open label (the patient and the physician know the drug treatment being received) of approximately 60 patients with multiple myeloma whose disease has progressed after initial response to VELCADE-based therapy. During each 21-day treatment cycle, patients will receive VELCADE by intravenous bolus on 4 designated days, and DOXIL by intravenous infusion on one designated day. Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity or up to a total of 8 cycles of therapy. Drug doses may be delayed or dropped as needed to allow for platelet transfusions or other treatment requirements. Patients responding to treatment at study end may be evaluated for continued treatment for as long as treatment can be tolerated and they continue to respond. After discontinuation of all study drugs, patients who have not had disease progression will be followed for 6 months after receiving the last dose of study drug. The primary endpoint is overall response rate as defined by the proportion of patients achieving either a complete response or a partial response. Response will be assessed at each cycle. Safety will be monitored throughout the study by physical examination, clinical laboratory testing, and the incidence and severity of reported adverse events. Overall safety will be summarized at study-end.
During each 21-day treatment cycle, patients will receive bortezomib 1.3 mg/m2 by intravenous bolus on Days 1, 4, 8 and 11 and pegylated liposomal doxorubicin 30 mg/m2 by intravenous infusion on Day 4.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed diagnosis of Multiple Myeloma
- Received prior courses of bortezomib (VELCADE)-based therapy
- Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy
- 60 days or more since the patient's last VELCADE dose
- Life expectancy > 3 months
- Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in M-protein
Exclusion Criteria:
- No patients with progressive disease while receiving an anthracycline-based regimen
- No patients with >2 prior regimens for the treatment of multiple myeloma
- No major surgery within 2 weeks before screening
- No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
- No patients known to be human immunodeficiency virus (HIV) positive
- No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
- No patients with an active systemic infection requiring treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 001
|
1.3 mg/m2 IV bolus on Days 1,4,8,11 of each 21-day cycle; 30 mg/m2 IV infusion on Day 4 of each 21 day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the overall response rate defined as the partial or complete response to treatment according to EBMT criteria. Overall response will be assessed at each treatment cycle up to 8 cycles.
Time Frame: Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.
|
Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary endpoints include time to disease progression (treatment start to disease progression or death due to progression); best response assessed by the investigator; duration of response; and overall survival (treatment start to death by any cause).
Time Frame: Day 1, Cycle 1 throughout treatment cycles and follow-up.
|
Day 1, Cycle 1 throughout treatment cycles and follow-up.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Bortezomib
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CR015091
- DOXILMMY2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on bortezomib; pegylated liposomal doxorubicin
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UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Leukemia | Breast Cancer | Ovarian Cancer | Unspecified Adult Solid Tumor, Protocol Specific | Multiple Myeloma and Plasma Cell NeoplasmUnited States
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Joseph TuscanoMillennium Pharmaceuticals, Inc.CompletedAcute Myelogenous LeukemiaUnited States
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Sun Yat-sen UniversityUnknown
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UNC Lineberger Comprehensive Cancer CenterMerck Sharp & Dohme LLCWithdrawnStudy of Vorinostat With Doxil and Bortezomib for Patients With Relapsed/Refractory Multiple MyelomaMultiple MyelomaUnited States
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GlaxoSmithKlineCompletedNeoplasms, OvarianUnited States
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Herbert Irving Comprehensive Cancer CenterNational Cancer Institute (NCI)UnknownMultiple Myeloma and Plasma Cell NeoplasmUnited States