An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy of CEP-18770 in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
After cycle 1, the start of treatment in each cycle may occur within a 3-day window. In
addition, after cycle 2, the start of treatment in cycle 3 may be delayed by 1 week if, in
the opinion of the investigator, the delay is warranted. If a patient cannot receive 75% of
the planned dose for any of the 3 agents (missing more than 1 dose of CEP-18770, or more
than 5 doses of lenalidomide [either consecutively or separately], or more than 1 dose of
dexamethasone [either consecutively or separately]), due to a drug-related adverse event,
the event will be considered a dose limiting toxicity (DLT), even if the grade of toxicity
is lower than specified DLT determination. Patients will receive intravenous (IV) CEP-18770
on days 1, 8, and 15, oral lenalidomide on days 1 through 21, and oral dexamethasone on days
1, 8, 15, and 22 of each 28-day cycle. Treatment with all 3 drugs will continue for up to 12
cycles (approximately 11 months), or until disease progression or intolerable toxicities.
Patients experiencing clinical benefit may continue to receive additional treatment at the
investigator's discretion and following sponsor notification. In part 2 of the study,
patients will receive CEP-18770 as a slow IV bolus (approximately 1 milliliter per minute)
at the maximum tolerated dose on days 1, 8, and 15 of every 28-day cycle. Patients who
complete or discontinue study drug treatment and whose disease has not progressed will have
study visits every 7-9 weeks during follow-up until disease progression, death, or until
they have been monitored for 1 year after the first administration of study drug, whichever
occurs first.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The patient's best response to treatment with CEP-18770 in combination with lenalidomide and dexamethasone
The primary efficacy variable is the overall response rate (ORR) defined as the number of patients in the full analysis set achieving a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) during the study divided by the total number of patients in the full analysis set.
Baseline to endpoint (defined as a maximum of 1 year after first administration of CEP-18770 or until disease progression)
No
Sponsor's Medical Expert, Medical Director - Clinical Research Oncology
Study Director
Cephalon
United States: Food and Drug Administration
C18770/2049
NCT01348919
August 2011
December 2013
Name | Location |
---|---|
Teva Investigational Site 1 | Augusta, Georgia |
Teva Investigational Site 3 | Lexington, Kentucky |
Teva Investigational Site 2 | Houston, Texas |