Clinical Trial: Combination Chemotherapy in Treating Patients With Multiple Myeloma

This study has been completed.

Sponsored by: Cleveland Clinic Foundation Hospital
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly diagnosed or previously treated multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: dexamethasone
 Drug: doxorubicin HCl liposome
 Drug: vincristine
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Doxorubicin HCl Liposome, Vincristine, and Dexamethasone in Newly Diagnosed and Previously Treated Patients with Multiple Myeloma

Further Study Details: 

Study start: November 1998

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Mohamad Ahmed Hussein,  Study Chair,  Cleveland Clinic Foundation Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066532; CCF-IRB-2006; NCI-V98-1459; SEQUUS-CCF-IRB-2006
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003493
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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