Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma
N/A
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma
OBJECTIVES: I. Assess the response rate and duration of response of multiple myeloma treated
with doxorubicin HCl liposome, vincristine, and dexamethasone. II. Define the qualitative
and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified into newly diagnosed (group A) and previously treated
(group B) patients. Patients receive doxorubicin HCl liposome IV over 2.5 hours, followed by
vincristine by bolus IV over 5 minutes on day 1. Dexamethasone is administered orally or by
IV on days 1-4. Treatment is repeated every 4 weeks for a minimum of 6 courses, and 2
courses after maximum response unless unacceptable toxic effects or disease progression
occur. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 33 patients from group A and 34 patients from group B will
be accrued for this study within 6-14 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed or previously treated
multiple myeloma At least one chemotherapy regimen and no more than four regimens
Pancytopenia related to multiple myeloma allowed At least 50% plasma cells in the bone
marrow Splenomegaly OR Plasma cell leukemia No solitary bone or solitary extramedullary
plasmacytoma
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
At least 3 months Hematopoietic: WBC at least 2,500/mm3 OR neutrophil count at least
1,000/mm3 (previously treated patients with platelet count at least 75,000/mm3 must have a
neutrophil count of greater than 500/mm3) Platelet count at least 75,000/mm3 (previously
treated patients must have platelet count at least 45,000/mm3) Thrombocytopenia related to
idiopathic thrombocytopenic purpura or B12 or folate deficiency allowed Hepatic: Bilirubin
no greater than upper limit of normal (ULN) ALT or AST no greater than 2 times ULN (unless
greater than 1/3 of liver is involved by tumor, in which case ALT or AST must be no
greater than 5 times ULN) Renal: Not specified Cardiovascular: LVEF at least 50% by MUGA
scan or echocardiogram No New York Heart Association class II or greater cardiac disease
Other: Not pregnant or nursing Fertile patients must use effective contraception No prior
malignancies within 5 years, except: Adequately treated basal or squamous cell skin cancer
Adequately treated carcinoma in situ of the cervix No uncontrollable physical, mental, or
emotional disorders No history of hypersensitivity to doxorubicin HCL or liposomal or
PEGylated formulations of other drugs No active infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Patients who have
previously failed treatment with doxorubicin HCl liposome, vincristine, and dexamethasone
(VAD) are allowed if anthracycline therapy has been at least 6 months, and prior
anthracycline exposure no greater than 300 mg/m2 No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Concurrent
radiotherapy to control pain or prevent fractures allowed Surgery: Prior surgery allowed
if recovered
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Mohamad A. Hussein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000066532
NCT ID:
NCT00003493
Start Date:
November 1998
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
