Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT00618345

Last Updated: 2011-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-08-31

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.

Detailed Description

OBJECTIVES:

Primary

• To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.

Secondary

• To evaluate the toxicity of everolimus in patients with multiple myeloma.
• To study the tumor cells and blood from patients entering this trial for laboratory correlates.

OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.

After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

everolimus

Intervention Type: DRUG

DNA analysis

Intervention Type: GENETIC

protein analysis

Intervention Type: GENETIC

western blotting

Intervention Type: GENETIC

flow cytometry

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

The Mayo Clinic

Principal Investigators

Thomas E. Witzig, MD

Role: STUDY_CHAIR

Mayo Clinic

Rafael Fonseca, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Roy Vivek, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC048E

Identifier Type: OTHER

Identifier Source: secondary_id

96-05

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000582257

Identifier Type: -

Identifier Source: org_study_id