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Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma


Phase 2
N/A
64 Years
Open (Enrolling)
Both
Multiple Myeloma, Plasma Cell Neoplasm

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Trial Information

Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related mortality

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Kenneth C. Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069109

NCT ID:

NCT00028600

Start Date:

November 2001

Completion Date:

March 2023

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Mount Sinai Medical CenterNew York, New York  10029
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint LouisSt Louis, Missouri  63110