Know Cancer

forgot password

Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma

Phase 2
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

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

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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




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



Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195