LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03773107
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The primary objective of Phase I is to establish the maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone. The primary objective of phase II is to evaluate progression-free survival (PFS) at 4 months in multiple myeloma subjects who receive the combination treatment carfilzomib, dexamethasone, and ruxolitinib.
- Detailed Description
This is an open-label, Phase I/II study of carfilzomib, ruxolitinib, and low-dose dexamethasone for carfilzomib-refractory multiple myeloma. Phase I is designed to evaluate overall maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone in the following cohorts: Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib. Phase II is designed to evaluate 4-month progression-free survival (PFS) in the following cohorts: Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen. Up to 18 evaluable subjects will be enrolled in Phase I over approximately 12 months. An additional 30 evaluable subjects will be enrolled in Phase II over 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I Dexamethasone Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib Phase I Carfilzomib Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib Phase I Ruxolitinib Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib Phase II Carfilzomib Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen Phase II Ruxolitinib Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen Phase II Dexamethasone Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicity (DLT) 28 days DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle) Clinical benefit will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of minimal response (MR) or better as determined by the IMWG criteria
Duration of Response approx. 5 years Duration of response will be defined as the time from first objective status assessment of response to the time of first documented disease progression or death.
Disease Control Rate Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle) Disease control will be determined for each subject as a binary variable indicating whether or not the subject achieved a disease response or stable disease for greater than or equal to 8 weeks
Progression-free Survival (PFS) approx. 5 years PFS is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death without progressive disease.
Objective Response Rate (ORR) Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle) Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of PR or better as per the IMWG criteria
Time to Best Response Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle) Time to best response will be defined as the time from initiation of ruxolitinib treatment to the time of best objective status assessment of response.
Overall Survival approx. 5 years Overall survival is defined as the duration from initiation of ruxolitinib treatment to the date of death from any cause.
Time to Progression approx. 5 years Time to progression (TTP) is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death.
Trial Locations
- Locations (2)
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States