Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00047203

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2002-09-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• No myocardial infarction within the past 6 months
• 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
• See Disease Characteristics
• No prior allogeneic stem cell transplantation

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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