drugset / Trial / NCT02773030
A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
Timeline
- Start
- 2016-10-14
- Primary completion
- 2024-05-09
- Completion
- 2028-07-28
Publications
- Amatangelo M, Flynt E, Stong N, Ray P, Van Oekelen O, Wang M, Ortiz M, Maciag P, Peluso T, Parekh S, van de Donk NWCJ, Lonial S, Thakurta A. Pharmacodynamic changes in tumor and immune cells drive iberdomide's clinical mechanisms of activity in relapsed and refractory multiple myeloma. Cell Rep Med. 2024 Jun 18;5(6):101571. doi: 10.1016/j.xcrm.2024.101571. Epub 2024 May 21.
- Lonial S, Popat R, Hulin C, Jagannath S, Oriol A, Richardson PG, Facon T, Weisel K, Larsen JT, Minnema MC, Abdallah AO, Badros AZ, Knop S, Stadtmauer EA, Cheng Y, Amatangelo M, Chen M, Nguyen TV, Amin A, Peluso T, van de Donk NWCJ. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lancet Haematol. 2022 Nov;9(11):e822-e832. doi: 10.1016/S2352-3026(22)00290-3. Epub 2022 Oct 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Subject | Carfilzomib | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Intravenous |
| Subject | Iberdomide | Small molecule | 0.15 mg | Oral |
| Subject | Iberdomide | Small molecule | 0.3 mg | Oral |
| Subject | Iberdomide | Small molecule | 1 mg | Oral |
| Subject | Iberdomide | Small molecule | 1.3 mg | Oral |
| Subject | Iberdomide | Small molecule | 1.6 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |