Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma
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.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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: A ≥ 50% reduction of measurable serum M-protein. A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h. A ≥ 50% decrease in the difference between involved and uninvolved FLC levels. ≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30% 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.
Up to 3 years
No
Shaji Kumar
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
NCI-2012-02795
NCT01096342
July 2009
December 2011
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |