Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028600

Purpose

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: tacrolimus Procedure: peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Cyclophosphamide Methotrexate Fludarabine Fludarabine monophosphate Tacrolimus anhydrous Tacrolimus Filgrastim Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Treatment-related mortality at 6 months [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	November 2001

Detailed Description:

OBJECTIVES:

Determine whether autologous peripheral blood stem cell transplantation (PBSCT) followed by non-myeloablative allogeneic PBSCT is associated with no more than 20% treatment-related mortality rates at 6 months in patients with multiple myeloma.
Determine the response rate of patients treated with this regimen.
Determine the percent donor chimerism in patients treated with this regimen.
Determine the rate of graft-vs-host disease in patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.
Determine the disease-free and overall survival of patients treated with this regimen.
Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.

Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.

Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover.

Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6.

After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks.

Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years.

PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of active multiple myeloma that requires treatment
- Durie-Salmon stage I, II, and III
No more than 1 progression after initial therapy
Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)
- No syngeneic donors
Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia)

PATIENT CHARACTERISTICS:

Age:

Under 65

Performance status:

NCI CTC 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count greater than 500/mm^3
Platelet count greater than 50,000/mm^3

Hepatic:

Bilirubin less than 2 mg/dL
AST less than 3 times upper limit of normal (ULN)
Alkaline phosphatase less than 3 times ULN

Renal:

Creatinine less than 2 mg/dL
Creatinine clearance greater than 40 mL/min

Cardiovascular:

LVEF at least 30% by MUGA scan

Pulmonary:

DLCO greater than 40% of predicted
No symptomatic pulmonary disease

Other:

HIV negative
No uncontrolled diabetes mellitus
No active serious infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 4 weeks since prior chemotherapy
Prior alkylating-agent therapy allowed if no more than 12 months duration

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

At least 4 weeks since prior surgery

Other:

All prior therapy no more than 18 months duration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028600

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Missouri
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
St Louis, Missouri, United States, 63110
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Kenneth C. Anderson, MD

Dana-Farber Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069109, CALGB-100001
Study First Received:	January 4, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00028600 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Melphalan
Vidarabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Reproductive Control Agents
Cyclophosphamide
Tacrolimus
Hemostatic Disorders

Hemorrhagic Disorders
Therapeutic Uses
Abortifacient Agents
Methotrexate
Cardiovascular Diseases
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Enzyme Inhibitors
Fludarabine monophosphate

ClinicalTrials.gov processed this record on November 27, 2009