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Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
This study has been completed.
Study NCT00047203   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2002   Last Updated: November 16, 2008   History of Changes

October 3, 2002
November 16, 2008
September 2002
 
 
 
Complete list of historical versions of study NCT00047203 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma

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.

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.

Phase II
Interventional
Treatment, Open Label
Multiple Myeloma and Plasma Cell Neoplasm
Drug: alvocidib
 
Dispenzieri A, Gertz MA, Lacy MQ, Geyer SM, Fitch TR, Fenton RG, Fonseca R, Isham CR, Ziesmer SC, Erlichman C, Bible KC. Flavopiridol in patients with relapsed or refractory multiple myeloma: a phase 2 trial with clinical and pharmacodynamic end-points. Haematologica. 2006 Mar;91(3):390-3. Epub 2006 Feb 17.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047203
 
CDR0000257567, MAYO-MC018B, NCI-5758
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Angela Dispenzieri, MD Mayo Clinic
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP