Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 to 70 NCI FHCRC-1743.00 NCT00054353

Objectives

1. Determine the efficacy of allogeneic hematopoietic stem cell transplantation, in terms of 1-year progression-free survival and overall survival, in patients with previously treated multiple myeloma.
2. Determine non-relapse mortality at day 100 in patients treated with this regimen.
3. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of multiple myeloma, meeting 1 of the following criteria:
  • Progressive disease after at least 1 prior syngeneic or autologous hematopoietic stem cell transplantation (indicated by greater than 25% increase in serum or urine paraprotein levels or appearance of new lytic bone lesions or plasmacytomas)
  • Unable to collect autologous peripheral blood stem cells due to poor marrow reserve OR contraindications to undergoing stem cell mobilization and has progressive disease after at least 4 prior courses of standard chemotherapy (e.g., dexamethasone/doxorubicin/vincristine)



• Availability of 1 of the following donors:
  • HLA genotypically matched identical sibling
  • HLA phenotypically matched relative
  • HLA phenotypically matched unrelated donor
    • Matched for serologically recognized HLA-A or B or C antigens and at least 5/6 HLA-A or B or C alleles
    • Matched for HLA-DRB1 and DQB1 alleles
  • No identical twins

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• No concurrent steroids for autologous or syngeneic graft-versus-host disease

Radiotherapy

• No other concurrent radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy
• At least 2 weeks since prior ganciclovir or foscarnet for previous CMV reactivation/infection
• No concurrent ganciclovir or foscarnet for previous CMV reactivation/infection
• No concurrent IV antibiotics for active infections
• No concurrent bisphosphonates during and for 30 days after transplantation

Patient Characteristics:

Age

• 18 to 70

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No chronic viral hepatitis with bilirubin > 3 mg/dL
• No biliary obstruction
• No symptomatic biliary disease
• No ascites related to portal hypertension
• No bridging fibrosis
• No bacterial or fungal liver abcess
• No fulminant liver failure
• No cirrhosis of liver with evidence of portal hypertension
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• No uncorrectable hepatic synthetic dysfunction evidenced by prolonged PT
• SGPT and SGOT no greater than 4 times ULN
• No alcoholic hepatitis
• No hepatic encephalopathy

Renal

• Creatinine clearance at least 40 mL/min

Cardiovascular

• LVEF at least 40%
• No symptomatic heart failure
• No poorly controlled hypertension

Pulmonary

• DLCO at least 50%
• No requirement for continuous supplemental oxygen

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 12 months after study participation
• HIV negative
• Cytomegalovirus (CMV)-antigenemia negative
• No impaired capacity that would preclude informed consent
• No persistent mucositis or gastrointestinal symptoms requiring hyperalimentation and/or IV hydration
• No prior or concurrent esophageal varices
• No nonhematologic malignancy within the past 5 years except nonmelanoma skin cancer currently in complete remission wtih ≤ 20% risk of recurrence
• No active nonhematologic malignancy except nonmelanoma skin cancer

Expected Enrollment

A total of 30 patients will be accrued for this study within 3 years.

Outcomes

Progression-free survival at 1 year
Treatment-related mortality at 100 days
Acute graft-versus-host disease grades III-IV

Outline

This is a multicenter study.

Patients receive fludarabine IV over 30 minutes on days -5 to -3 and melphalan IV over 15-20 minutes on day -2. Patients undergo total body irradiation and allogeneic hematopoietic stem cell transplantation on day 0.

Patients also receive graft-versus-host disease prophylaxis according to the type of donor.

• Related donor: Patients receive oral cyclosporine every 12 hours on days -3 to 80 followed by a taper until day 180 and oral mycophenolate mofetil every 12 hours on days 0-27.



• Unrelated donor: Patients receive oral cyclosporine every 12 hours on days -3 to 100 followed by a taper until day 177 and oral mycophenolate mofetil every 8 hours on days 0-40 followed by a taper until day 96.

Patients are followed at days 28, 56, and 84; at months 6, 12, 18, and 24; and then annually for 5 years.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Marco Mielcarek, MD, Protocol chair		Ph: 206-667-2827

Registry Information
Official Title		Reduced-Intensity Allogeneic HSC Transplantation from HLA-Matched Related and Unrelated Donors for Patients with Multiple Myeloma
Trial Start Date		2002-10-21
Trial Completion Date		2008-02-20
Registered in ClinicalTrials.gov		NCT00054353
Date Submitted to PDQ		2002-12-31
Information Last Verified		2008-04-06
NCI Grant/Contract Number		CA78902, CA15704

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