Clinical trial NCT00047203 (phase 2, status: completed)
Conditions: refractory multiple myeloma, stage i multiple myeloma, stage ii multiple myeloma, stage iii multiple myeloma
ICD codes: D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22, C90.01, C90.02, C90.00, C90.01, C90.02, C90.00, C90.01, C90.02, C90.00
Drugs: alvocidib
SMILES: CN1CC[C@@H]([C@H](O)C1)C1=C(O)C=C(O)C2=C1OC(=CC2=O)C1=CC=CC=C1Cl
Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  At least 10 days since prior thalidomide

          -  No concurrent biologic therapy

          -  See Disease Characteristics

          -  At least 2 weeks since prior myelosuppressive chemotherapy

          -  No other concurrent chemotherapy

          -  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

          -  At least 10 days since prior bortezomib or tipifarnib

          -  Concurrent bisphosphonates allowed if on stable dose before study entry