Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00618345

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: everolimus Genetic: DNA analysis Genetic: protein analysis Genetic: western blotting Other: flow cytometry Other: laboratory biomarker analysis Procedure: biopsy	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	35
Study Start Date:	March 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618345

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Thomas E. Witzig, MD	Mayo Clinic
Investigator:	Rafael Fonseca, MD	Mayo Clinic Scottsdale
Investigator:	Vivek Roy, MD, FACP	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000582257, MAYO-MC048E
Study First Received:	February 19, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00618345 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

refractory multiple myeloma

Study placed in the following topic categories:

Everolimus
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Immunosuppressive Agents
Multiple Myeloma
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Everolimus
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009