LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03773107
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carfilzomib — DRUG
    Irreversible proteasome inhibitor
  • Ruxolitinib — DRUG
    Oral JAK inhibitor
  • Dexamethasone — DRUG
    glucocorticoid

Study Details

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.

Key Dates

Start date
Jan 3, 2019
Status verified
Jan 2025
Primary completion
Nov 7, 2022
Completion
Feb 21, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I
    Cohort 1) 5mg ruxolitinib, Cohort 2) 10mg ruxolitinib, Cohort 3) 15mg ruxolitinib
  • Other: Phase II
    Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201-
Levine Cancer InstituteCharlotteNorth Carolina28204-

Find similar trials in Detroit, MI

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Karmanos Cancer Institute· Detroit, MILevine Cancer Institute· Charlotte, NC

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