September 2, 2005 |
December 2, 2008 |
June 2005 |
efficacy of drug combination as therapy for myeloma [ Time Frame: duration of study ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00148317 on ClinicalTrials.gov Archive Site |
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Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma |
A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients |
PRIMARY STUDY OBJECTIVES
To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:
- Patients post first line therapy
- Patients with relapsed/refractory disease who are bortezomib-naïve
- To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.
SECONDARY STUDY OBJECTIVES
- To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients).
- To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
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Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Multiple Myeloma |
Drug: Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide |
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Recruiting |
60 |
December 2009 |
December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
- Prior treatment with bortezomib.
- Peripheral neuropathy of > Grade 2 as defined by CTCAE Version 3.0 (see Appendix II)
- History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL.
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
- NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months.
- Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Known HIV or hepatitis A, B, or C positivity
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).
- No prior anti-myeloma therapy within 2 weeks of treatment initiation.
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Both |
18 Years and older |
No |
Contact: Ruben Niesvizky, MD |
212-746-3964 |
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United States |
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NCT00148317 |
Ruben Niesvizky, MD, Weill Cornell Medical College |
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Weill Medical College of Cornell University |
Millennium Pharmaceuticals, Inc. |
Principal Investigator: |
Ruben Niesvizky, MD |
Weill Medical College of Cornell University |
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Weill Medical College of Cornell University |
December 2008 |