Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00618345 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000582257P30CA015083MC048E96-05
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein

Secondary Outcomes (1)

• Toxicity

Interventions

everolimus DRUG

DNA analysis GENETIC

protein analysis GENETIC

western blotting GENETIC

flow cytometry OTHER

laboratory biomarker analysis OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Everolimus; Blotting, Western; Flow Cytometry; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Thomas E. Witzig, MD

  Mayo Clinic

  STUDY CHAIR

• Rafael Fonseca, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Roy Vivek, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: March 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: August 1, 2008
• Last Updated: May 16, 2011

Record last verified: 2011-05