Status:
COMPLETED
Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 subs...
Eligibility Criteria
Inclusion
- Subject must voluntarily sign and understand written informed consent.
- Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I.
- Measurable disease as defined the following:
- For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
- For patients with relapsed/refractory disease, \> 0.5 g/dL serum monoclonal protein, \> 0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- Age \> or = than 18 years at the time of signing the informed consent form.
- Karnofsky performance status\> or =70% (\>60% if due to bony involvement of myeloma).
- Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(\>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens .
- If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study.
- Life expectancy \> 12 weeks.
- Absolute neutrophil count (ANC)\> or = 1500 cells/mm3 (\> or = 1000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma)
- Platelets count \> or = 50,000/mm3 (\> or = 30,000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma)
- Hemoglobin \> 9.0 g/dL
- Serum SGOT/AST \<3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT \<3.0 x upper limits of normal (ULN)
- Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min
- Serum total bilirubin \< 1.5 x ULN
- Patients must have a MUGA scan with LVEF \>50%
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00148317
Start Date
June 1 2005
End Date
November 1 2012
Last Update
July 18 2017
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021