Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618345
• Other study ID #: CDR0000582257
• Secondary ID: P30CA015083MC048
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2008
• Last updated: May 13, 2011
• Start date: March 2005
• Est. completion date: August 2008

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2008
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• everolimus

Genetic:
• DNA analysis

• protein analysis

• western blotting

Other:
• flow cytometry

• laboratory biomarker analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein			No
Secondary	Toxicity			Yes