Clinical Trial: Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma

This study is no longer recruiting patients.

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 cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Randomized phase I/II trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation followed by immunotherapy in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
Infection
refractory plasma cell neoplasm
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: autologous lymphocytes
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: melphalan
 Drug: pneumococcal vaccine
 Drug: tumor infiltrating lymphocytes
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: infection prophylaxis/management
 Procedure: leukocyte therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
 Procedure: tumor infiltrating lymphocyte therapy
Phase I
Phase II

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

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Randomized Study of High-Dose Therapy and Autologous Peripheral Blood Stem Cell Transplantation Followed By Immunotherapy With Costimulated Autologous T Cells Plus Pneumococcal Conjugate Vaccine in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study.

Patients receive cyclophosphamide IV over 12 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2. Patients undergo leukapheresis to collect mononuclear cells for autologous T cells (ATCs) and peripheral blood stem cells (PBSCs). ATCs are generated by ex vivo expansion for 8-14 days and selection for CD3+/CD28+ cells.

Patients then receive high-dose therapy comprising carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1 or melphalan IV alone on days -2 and -1 (or day -1 only). Autologous PBSCs are reinfused on day 0. Patients also receive G-CSF SC beginning on day 1 and continuing until blood counts recover.

Patients who choose to receive pneumococcal conjugate vaccine (PCV) are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive PCV intramuscularly prior to transplantation (10-14 days before lymphocyte collection) and post-transplantation (1 and 3 months) plus costimulated ATCs IV over 20-60 minutes around day 12-14 post-transplantation.
  • Arm II: Patients receive PCV as in arm I but receive ATCs around day 100 post-transplantation.
  • Arm III: Patients receive PCV post-transplantation only (at 1 and 3 months) plus ATCs as in arm I.
  • Arm IV: Patients receive PCV as in arm III and ATCs as in arm II. Patients who choose not to receive the PCV receive ATCs on about day 12-14 after PBSC transplantation.

All patients are offered standard pneumococcal polysaccharide vaccine at 12 months.

Patients are followed twice weekly until day 60, weekly for 4 months, monthly for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 14 months.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 to 80

Performance status

  • ECOG 0-2 (ECOG 3-4 allowed if based solely on bone pain)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

Renal

  • Creatinine no greater than 3.0 mg/dL
  • No dialysis

Cardiovascular

  • LVEF at least 45% unless no evidence of untreated clinically significant functional impairment

Pulmonary

  • FEV_1 and FVC at least 50% of predicted
  • Total lung capacity at least 50% of predicted
  • DLCO at least 50% of predicted
  • Mild to moderate pulmonary impairment (lower DLCO) allowed but patients would not receive study carmustine
  • Patients unable to complete pulmonary function test due to bone pain or fracture must have high-resolution CT scan of the chest and arterial partial pressure of oxygen greater than 70

Other

  • No active infections requiring IV antibiotics
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location Information


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

Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States

Study chairs or principal investigators

Aaron P. Rapoport, MD,  Study Chair,  University of Maryland Greenebaum Cancer Center   

More Information

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

Study ID Numbers:  CDR0000256870; MSGCC-0065; UPCC-6401; NCI-V02-1709
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00046852
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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