NCT01096342

Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	dinaciclib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2010-03-31
• Last updated: 2014-06-18
• Results posted: 2013-02-25

Locations

6 sites across 2 countries: United States, Singapore