Clinical Trial: Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma

This study has been completed.

Sponsored by: University of Maryland Greenebaum Cancer Center
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma that has been treated for longer than 12 months.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: carmustine
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: etoposide
 Drug: gemcitabine
 Drug: melphalan
 Drug: paclitaxel
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 Peripheral Stem Cell Transplantation With Gemcitabine and High Dose Carmustine and Melphalan Followed by Consolidation Therapy With Gemcitabine and Cyclophosphamide/Dexamethasone/Etoposide/Cisplatin (DCEP) and Dexamethasone/Paclitaxel/Cisplatin in Patients with Multiple Myeloma

Further Study Details: 

Study start: January 1999

OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients receiving peripheral blood stem cells supported by gemcitabine and high dose carmustine and melphalan followed by consolidation therapy with gemcitabine plus cyclophosphamide/dexamethasone/etoposide/cisplatin (DCEP) and dexamethasone/paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison with historical data in this patient population. III. Evaluate the feasibility of chemotherapy with gemcitabine plus DCEP and dexamethasone/paclitaxel/cisplatin following autotransplantation in these patients.

PROTOCOL OUTLINE: Patients receive gemcitabine IV over 100 minutes on day -5 and again 6 hours after administration of carmustine IV over 2 hours on day -2, followed by melphalan IV over 20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on day 0. At 3 months and 9 months, patients with adequate hematologic counts receive cyclophosphamide IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. On day 3 of continuous infusions, gemcitabine is given over 100 minutes. At 6 and 12 months after autotransplant, patients receive oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and cisplatin IV over 24 hours on day 3. Patients are followed every 6 weeks to 3 months until death.

PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued within 2.5 years.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven multiple myeloma with greater than 12 months of prior therapy
  • Bone marrow plasmacytosis at least 30% or protein criteria present
  • No obvious myelodysplastic changes in the bone marrow
  • No CNS disease

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: At least 4 weeks since prior chemotherapy
  • Endocrine therapy: Prior steroid therapy allowed
  • Radiotherapy: At least 4 weeks since prior radiotherapy
  • Surgery: Not specified

--Patient Characteristics--

  • Performance status: SWOG 0-2 (3-4 acceptable if based solely on bone pain)
  • Life expectancy: Not specified
  • Hematopoietic: CD34+ at least 4,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT or SGPT no greater than 4 times upper limit of normal; No active or chronic hepatitis or liver cirrhosis
  • Renal: Creatinine no greater than 3.0 mg/dL
  • Cardiovascular: LVEF greater than 50%
  • Pulmonary: FEV1 or FVC at least 50% of predicted DLCO at least 50% of predicted; Patients unable to complete pulmonary function tests must have a CT scan of the chest and acceptable arterial blood gases of PO2 greater than 70
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No active infection requiring IV antibiotics

Location Information


Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Study chairs or principal investigators

Barry R. Meisenberg,  Study Chair,  University of Maryland Greenebaum Cancer Center   

More Information

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

Study ID Numbers:  CDR0000066405; MSGCC-9731; NCI-V98-1437
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003401
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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