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

Alternate Title

O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	CWRU-1A96 NCI-T97-0021, NCT00004072, T97-0021

Objectives

1. Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
2. Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient population.

Entry Criteria

Disease Characteristics:

• Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria:
  • Previously untreated
  • Primary refractory
  • Relapsing disease



• Major criteria:
  • Plasmacytomas on tissue biopsy
  • Bone marrow plasmacytosis with greater than 30% plasma cells
  • Monoclonal globulin spike on serum electrophoresis
    • Greater than 3.5 g/dL for G peaks or greater than 2.0 g for A peaks
    • Greater than 1.0 g/24 hours of kappa or lambda light chain excretion on urine electrophoresis in the absence of amyloidosis



• Minor criteria:
  • 10%-30% bone marrow plasmacytosis (criterion A)
  • Presence of monoclonal globulin spike but less than the levels under major criteria (criterion B)
  • Lytic bone lesions (criterion C)
  • IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL (criterion D)



• Must meet one of the following:
  • A minimum of 1 major criterion and 1 minor criterion
  • 3 minor criteria, including criteria A and B

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 1 prior chemotherapy regimen containing an alkylating agent for multiple myeloma
• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Prior corticosteroids for multiple myeloma allowed

Radiotherapy:

• No prior pelvic radiotherapy or radiotherapy to more than 25% of bone marrow

Surgery:

• Not specified

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Hemoglobin greater than 9 g/dL (transfusions allowed)

Hepatic:

• Bilirubin less than 1.5 mg/dL
• AST/ALT less than 2 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min
• Calcium less than 14 mg/dL

Pulmonary:

• No prior or concurrent active, symptomatic respiratory disease
• Corrected DLCO at least 60% predicted

Other:

• Controlled diabetes mellitus allowed
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation

Expected Enrollment

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

Outline

Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response (partial or complete response or stable or plateau disease).

Patients are followed every 2 months.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Stanton Gerson, MD, Protocol chair		Ph: 216-844-8562

Registry Information
Official Title		Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients with Multiple Myeloma
Trial Start Date		1999-09-21
Registered in ClinicalTrials.gov		NCT00004072
Date Submitted to PDQ		1999-08-25
Information Last Verified		2004-07-26
NCI Grant/Contract Number		P30-CA43703, U01-CA62502

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