Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma|
- Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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.
- Progression-free Survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- Duration of Response [ 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 ] [ Designated as safety issue: No ]The distribution of duration of response will be estimated using the method of Kaplan-Meier.
|Study Start Date:||July 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Phase II
Patients receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given IV, 50 mg/m^2
I. To evaluate the efficacy (overall response rate) of single agent SCH 727965 in patients with relapsed or refractory multiple myeloma.
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.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Shaji Kumar||Mayo Clinic|