Clinical trial · Interventional
AE-941 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Neovastat (AE-941) in Refractory and Early Relapse Multiple Myeloma Patients
NCT00022282CI-TRIAL-00009605completedPhase 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: AE-941 may help to slow the growth of multiple myeloma. PURPOSE: Phase II trial to study the effectiveness of neovastat in treating patients who have relapsed or refractory 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| shark cartilage extract AE-941 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) according to the Durie and Salmon criteria * Refractory to or in early relapse after standard chemotherapy with or without stem cell transplantation * Measurable disease * Quantifiable IgM, IgG, or IgA paraprotein in serum AND/OR * Bence-Jones protein in urine * No plasma cell leukemia (more than 20% plasma cells in peripheral blood and an absolute plasma cell count of at least 2,000/mm3) * No nonsecretory MM * No spinal cord compression PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 6 months Hematopoietic: * No clinical symptoms of hyperviscosity Hepatic: * Not specified Renal: * Creatinine no greater than 2 times upper limit of normal * Calcium no greater than 11 mg/dL Other: * No other prior malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix * No severe allergy to fish or seafood * No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection) * No significant medical or psychiatric condition that would preclude study participation * Not pregnant * Negative pregnancy test * Fertile patients must use adequate contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior history of treatment with thalidomide for more than 14 days duration * At least 4 weeks since prior biological therapy for MM * Concurrent epoetin alfa allowed Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy for MM Endocrine therapy: * At least 4 weeks since prior steroid therapy for MM * No prednisone maintenance therapy Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent palliative or curative radiotherapy Surgery: * Not specified Other: * At least 28 days since other prior shark cartilage products * At least 28 days since other prior experimental therapeutic agents * Concurrent monthly bisphosphonate (pamidronates) infusions allowed * No other concurrent anticancer treatment * No other concurrent shark cartilage products * No other concurrent therapies for MM
References
Publications (0)
Data not yet available
No reference posted for this study.