Clinical Trial: Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma

This study is no longer recruiting patients.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide in treating patients who have stage I, stage II, or stage III multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: busulfan
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: interferon alfa
 Drug: melphalan
 Drug: pamidronate
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: growth factor antagonist therapy
 Procedure: high-dose chemotherapy
 Procedure: interferon therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Sequential High-Dose Melphalan, Busulfan, and Cyclophosphamide Followed By Peripheral Blood Stem Cell Rescue, Interferon alfa, Pamidronate, and Thalidomide in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) or IV twice a day beginning on day 2 and continuing until peripheral blood stem cells (PBSCs) are collected. PBSCs are collected beginning on day 10.

Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.

Patients with responding or stable disease after chemotherapy receive maintenance therapy with interferon alfa beginning 14-20 weeks after day 0 of the second course of chemotherapy. Interferon alfa is administered SC 3 times a week for 3 years. Patients also receive pamidronate IV every 4 weeks until disease progression. Patients who are not in complete remission (CR) 6 months after completing the second course of chemotherapy receive oral thalidomide daily for a maximum of 1 year or for 3 months after achieving CR.

Patients are followed monthly for 1 year, every 3 months for 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within approximately 2.5 years.

Eligibility

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage I-III multiple myeloma
  • Less than 18 months since diagnosis
  • Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy
  • At least 25% increase in M protein levels or Bence Jones excretion
  • Hemoglobin no greater than 10.5 g/dL
  • Hypercalcemia
  • Frequent infections
  • Rise in serum creatinine above normal on 2 separate occasions
  • Nonquantifiable monoclonal proteins allowed if other criteria for multiple myeloma or smoldering myeloma are met
  • Response/status after induction therapy:
  • Responding or stable disease AND no greater than 40% myelomatous involvement of bone marrow
  • No Waldenstrom's macroglobulinemia

PATIENT CHARACTERISTICS: Age:

  • 65 and under

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT less than 2.5 times upper limit of normal
  • Hepatitis B antigen or hepatitis C RNA negative

Renal:

  • See Disease Characteristics
  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance greater than 65 mL/min

Cardiovascular:

  • Cardiac ejection fraction at least 50% by MUGA or echocardiogram

Pulmonary:

  • FEV_1 greater than 60%
  • DLCO greater than 50% of predicted lower limit

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified

Location Information


Arizona
      Banner Good Samaritan Medical Center, Phoenix,  Arizona,  85006,  United States

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States

More Information

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

Study ID Numbers:  CDR0000067301; CHNMC-IRB-99021; NCI-G99-1583; NCT00004088
Record last reviewed:  February 2005
Last Updated:  February 23, 2005
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004088
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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

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