Status:
TERMINATED
Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
University of California, San Francisco
Conditions:
Multiple Myeloma
Patient Participation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has been heartening, ...
Detailed Description
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2 Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 m...
Eligibility Criteria
Inclusion
- Disease Characteristics:
- Patient previously diagnosed with multiple myeloma; Durie-Salmon Stage I, II, or III based on standard criteria
- Progressive disease. For non-secretory multiple myeloma, progressive disease is defined as bone marrow biopsy with \> 25% increase in plasma cells or an absolute increase of at least 10% over prior known level. Alternatively, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium \>11.5 mg/dL), or relapse from complete response.
- Patient Characteristics:
- 18 yrs or older
- Patient has given voluntary written informed consent.
- Unless post-menopausal or surgically sterilized, a female must be willing to use an acceptable method of birth control
- Male patient must agree to use an acceptable method for contraception for the duration of the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Life expectancy is at least 3 months.
- • Absolute Neutrophil Count (ANC) over 1,000/ul without the use of colony stimulating factors
- Platelets over 50,000/ul without transfusion support 7 days
- Bilirubin 2.0 mg/dl or less
- aspartate aminotransferase (AST) 4 times or less upper limit normal Prior Therapy for Multiple Myeloma: Patients must have had at least 2 prior therapeutic regimens
Exclusion
- Pregnant or breast feeding
- History of allergic reaction to compounds containing boron or mannitol.
- Active uncontrolled viral (including HIV), bacterial, or fungal infection.
- Grade III or IV toxicity due to previous anti-neoplastic therapy
- More than Grade 2 motor or sensory neuropathy
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia.
- For any patients whose lifetime cumulative doxorubicin dose exceeds 400mg/m2, patients with left ventricular ejection fraction (LVEF) less than 35% by multigated acquisition (MUGA) .
- Concurrent administration of liposomal doxorubicin, melphalan, and bortezomib (single or two drug combinations of these are permissible)
- Less than 3 weeks since most recent chemotherapy or concurrent chemotherapy
- Use of corticosteroids (mroe than 10 mg prednisone/day or equivalent)
Key Trial Info
Start Date :
October 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00985907
Start Date
October 28 2004
End Date
January 12 2010
Last Update
June 17 2020
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011