Clinical trial · Interventional
Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
NCT00618345CI-TRIAL-00004833completedPhase 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: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| DNA analysis | Genetic | — | UNRESOLVED |
| everolimus | Drug | Everolimus | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
| western blotting | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
Secondary outcomes (1)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma, meeting 1 of the following criteria: * Monoclonal protein in the serum of ≥ 1 g/dL * Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours * Measurable light chains by free light chain assay of ≥ 10 mg/dL * Measurable plasmacytoma * Must have received prior therapy and have relapsed or refractory disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal) * AST ≤ 3 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * Calcium \< 11 mg/dL * No uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 weeks since prior cytotoxic chemotherapy * At least 2 weeks since prior biologic therapy or radiotherapy * At least 2 weeks since prior corticosteroids * Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma * No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
References
Publications (0)
Data not yet available
No reference posted for this study.