Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to test a new drug called carfilzomib. It is a type of drug called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells make a lot of protein and are especially in need of a functional proteasome to survive.
Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It is considered an experimental drug. Previous studies have shown that carfilzomib is safe to use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma|
- To evaluate the best Overall Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Defined as stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) to four cycles of infusional carfilzomib with or without dexamethasone in patients with multiple myeloma (MM) meeting eligibility criteria.
- To evaluate the safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Toxicity scoring will be done using NCI CTCAE v4.0.
- time to progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Median TTP defined as the time from start of treatment to disease progression. Participants who do not have disease progression will be censored at their date of last response assessment or date of death.
- duration of response (DOR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]DOR is defined as the time from first evidence of PR or better [first observation of PR before confirmation] to disease progression, with deaths owing to causes other than progression censored.
- progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Rate of PFS defined as the time from start of treatment to disease progression or death. PFS will be calculated for all patients who have received at least one dose of carfilzomib. Median duration of PFS will be reported.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
A single arm, open-label, single institution phase 2 clinical trial is planned.
Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Nikoletta Lendvai, MD,PhD||Memorial Sloan-Kettering Cancer Center|