This phase II trial is studying how well giving dinaciclib works in treating patients with relapsed or refractory multiple myeloma. Dinaciclib may stop the growth of cancer cells by clocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To evaluate the efficacy (overall response rate) of single agent SCH 727965 in patients with relapsed or refractory multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the toxicities associated with use of single agent SCH 727965 in patients with relapsed or refractory multiple myeloma. II. To evaluate the response duration and progression free survival among patients with relapsed or refractory multiple myeloma undergoing treatment with single agent SCH 727965. III. To study the effect of SCH 727965 on myeloma cell proliferation, apoptotic rates and to assess the ability of the drug to inhibit drug targets (cyclin dependent kinases, cdk in the myeloma cell. OUTLINE: This is a multicenter, dose-escalation study. Patients receive dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood and bone marrow samples are collected periodically for correlative studies. (US sites only) After completion of study treatment, patients are followed up for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Given IV
Correlative studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.
Complete Response (CR): Negative immunofixation of serum and urine Normalization of FLC ratio \< 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas Stringent Complete Response (sCR): CR, as above, with absence of clonal cells in bone marrow Partial Response (PR): One of the following: 1. A ≥ 50% reduction of measurable serum M-protein. 2. A reduction in 24h measurable urinary M-protein by ≥ 90% or to \<200 mg per 24h. 3. A ≥ 50% decrease in the difference between involved and uninvolved FLC levels. 4. ≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30% 5. A ≥50% reduction in the size of soft tissue plasmacytomas. Very Good Partial Response (VGPR): PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis.
Time frame: Up to 3 years
Progression-free Survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to progression or death due to any cause, assessed up to 3 years
Duration of Response
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Time frame: Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
National University Hospital
Singapore, Singapore