Clinical trial · Interventional
Beta Alethine in Treating Patients With Myeloma
Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma
NCT00006466CI-TRIAL-00013031unknownPhase 1 / Phase 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: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have myeloma.
Conditions
Conditions (2)
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 | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta alethine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven myeloma * Multiple myeloma * Indolent myeloma with slowly progressive bone pathology * Smoldering myeloma with no bone pathology but a progressive increase in M-protein * Solitary myeloma OR * Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level * Measurable M-protein or Bence Jones protein * Indolent disease not requiring therapy allowed * No clinical signs or evidence of active brain involvement or leptomeningeal disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * At least 4 months Hematopoietic: * See Disease Characteristics * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 2.0 mg/dL * Transaminases no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL * Creatinine clearance at least 60 mL/min Cardiovascular: * No acute changes on electrocardiogram * No uncontrolled angina, heart failure, or arrhythmia Other: * Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L) * HIV negative * No AIDS * No active bacterial infection (e.g., abscess) or with fistula * No history of alcoholism, drug addiction, or psychotic disorders that would preclude study * No other nonmalignant disease that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy or cytokines Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin) Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy to greater than 25% of bone marrow Surgery: * Recovered from any prior surgery * No prior solid organ transplantation Other: * No other concurrent investigational agent * No concurrent immunosuppressive agents * No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs
References
Publications (0)
Data not yet available
No reference posted for this study.