Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00047203 | Completed Phase 2

• 4 other identifiers: NCI-2012-02496MC018BN01CM17104CDR0000257567
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.

  Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.

  First 3 months of treatment

Secondary Outcomes (2)

• Overall survival time

  Time from registration to death due to any cause, assessed up to 1 year

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 1 year

Study Arms (1)

Treatment (flavopiridol)

EXPERIMENTAL

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.

Drug: alvocidib

Interventions

alvocidib DRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275

Treatment (flavopiridol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Performance status - ECOG 0-2
• Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)
• Absolute neutrophil count at least 750/mm\^3
• 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
• Creatinine no greater than 3 mg/dL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Angela Dispenzieri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: September 1, 2006
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)