A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma
Hackensack Meridian Health
Summary
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
Description
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM. As part of a dose escalation phase, the first 10 patients will be enrolled at dose level -1 (Iberdomide 1.1 mg po daily days 1-21). Two months after the first 10 patients have completed at least 2 cycles of therapy in dose level -1, an Independent Safety Review Committee will review the safety data. Assuming the combination is determined to have adequate safety and tolerability, 10 patients will be enrolled at dose level 1 (Iber…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Documented newly diagnosed multiple myeloma a. At least 25% of patients accrued should be high risk as defined by IMWG or mSMART criteria. 2. Patient should be deemed transplant eligible. 3. Patients may not have had more than 1 cycle of prior induction therapy. If a patient has had 1 cycle of prior multiple myeloma therapy, the patient must have had documented measurable disease prior to initiation of cycle 1. 4. Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent…
Interventions
- DrugCarfilzomib
20 mg/m2 C1D1; 56 mg/m2 thereafter
- DrugIberdomide
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
- DrugOral Dexamethasone
40 mg (\<=75 years old); 20 mg (\>75 years old)
Locations (2)
- Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- John Theurer Cancer CenterHackensack, New Jersey