Clinical trial · Interventional
O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma
NCT00004072CI-TRIAL-00003565completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine with carmustine in treating patients who have previously untreated, refractory, or relapsing multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
- timeFrame
- Every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response. Patients are followed every 2 months.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
* 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
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 specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.