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Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
This study has been completed.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047203
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: alvocidib
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Alvocidib Flavopiridol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma

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

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol.
  • Determine the disease-free survival and overall survival of patients treated with this drug.
  • Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation status, and BCRP expression in patients treated with this drug.
  • Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study within approximately 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment

    • Durie-Salmon stage I or greater at diagnosis

      • Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells
      • Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours
  • Must have received at least 1, but no more than 5 prior therapy regimens

    • Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens
    • No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide)
    • Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 750/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 3 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months

Other

  • Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed
  • No other uncontrolled serious medical condition
  • No uncontrolled infection
  • No other active malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation
  • At least 10 days since prior thalidomide
  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior myelosuppressive chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)

    • Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 10 days since prior bortezomib or tipifarnib
  • Concurrent bisphosphonates allowed if on stable dose before study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047203

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University College of Medicine
Washington, District of Columbia, United States, 20059
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-5256
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Angela Dispenzieri, MD Mayo Clinic
  More Information

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

Publications of Results:
Study ID Numbers: CDR0000257567, MAYO-MC018B, NCI-5758
Study First Received: October 3, 2002
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00047203  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Flavopiridol
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009