Status:
COMPLETED
Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethaso...
Detailed Description
OBJECTIVES: * Determine the efficacy and safety of bortezomib, pegylated doxorubicin hydrochloride liposome, and dexamethasone followed by thalidomide and dexamethasone with or without bortezomib in ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically and serologically confirmed multiple myeloma meeting one of the following criteria:
- High-risk myeloma, defined as symptomatic International Staging System (ISS) stage 2 or 3 multiple myeloma
- Soft-tissue involvement with myeloma in the form of a soft-tissue plasmacytoma
- Extension of a plasmacytoma into soft tissues
- Primary resistant myeloma, defined as unchanged or progressive myeloma despite two courses of standard treatment
- No ISS stage 1 multiple myeloma without soft-tissue involvement
- No smoldering myeloma
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy \> 16 weeks
- Absolute granulocyte count ≥ 1,500/mm³ (unless low granulocyte counts are due to multiple myeloma)
- Platelet count ≥ 100,000/mm³ (unless low platelet counts are due to multiple myeloma)
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT \< 3 times upper limit of normal (ULN)
- Alkaline phosphatase \< 3 times ULN
- LVEF ≥ 50% by MUGA or ECHO
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception 4 months prior to, during, and for 4 weeks after completion of study treatment
- No active thromboembolic disease on anticoagulation
- No active angina or myocardial infarction within the past 6 months
- No pre-existing neuropathy or sensory or neuropathic pain ≥ grade 2
- No concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
- Prior malignancies that have not required antitumor treatment within the past 24 months allowed
- Patients with a history of stage I or II (T1a/b) prostate cancer (detected incidentally at transurethral resection of prostate \[TURP\] and comprising \< 5% of resected tissue) allowed if the prostate-specific antigen has remained normal since TURP
- No known HIV positivity or AIDS-related illness
- No other medical condition or reason that, in the opinion of the investigator, would preclude study compliance
- No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or to components of pegylated doxorubicin hydrochloride liposome, bortezomib, boron, or mannitol
- PRIOR CONCURRENT THERAPY:
- Prior radiotherapy allowed
- No more than 2 courses of prior initial chemotherapy for multiple myeloma
- No prior bortezomib
- No prior high-dose steroids (not including taper) for more than 1 month in duration for emergent indications, such as hypercalcemia or life-threatening lesions (e.g., spinal cord compromise) (in high-risk patients)
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00458705
Start Date
November 1 2006
End Date
April 1 2011
Last Update
January 22 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065