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Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000582257

NCT ID:

NCT00618345

Start Date:

March 2005

Completion Date:

August 2008

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

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