A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
CC-220: CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Dexamethasone: Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Daratumumab: Specified dose on specified days
Bortezomib: Specified dose on specified days
Carfilzomib: Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.
Daratumumab - 16mg/kg: Daratumumab (DARA) 16mg/kg by intravenous infusion on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
Bortezomib (BTZ): Bortezomib 1.3 mg/m\^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.
Daratumumab- 1800mg: Daratumumab (DARA) 1800 mg by subcutaneous injection on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Dose Limiting Toxicities in Part 1. — From first dose to 28 days post last dose (up to 28 days)
The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD. Hematologic DLTs: Grade 4 neutropenia (ANC \<500/μL for \>5 days) Grade 3 neutropenia (ANC \<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours. Non-hematologic DLT: Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management. - Overall Response Rate (ORR) in Cohort D and Cohort H2 — Approximately on average (Cohort D: 21.14 weeks, Cohort H2: 22.11 Weeks)
Tumor response, including progressive disease (PD) according to the IMWG Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better.
Trial sites (162)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 102 | Scottsdale | Arizona | |
| Mayo Clinic | Scottsdale | Arizona | |
| Local Institution - 107 | Little Rock | Arkansas | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Local Institution - 101 | Atlanta | Georgia | |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | |
| Local Institution - 120 | Chicago | Illinois | |
| Robert H Lurie Comprehensive Cancer Center NW Univ | Chicago | Illinois | |
| Local Institution - 113 | Fairway | Kansas | |
| University of Kansas Cancer Center | Fairway | Kansas | |
| Local Institution - 106 | Baltimore | Maryland | |
| University of Maryland School of Med | Baltimore | Maryland | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Local Institution - 114 | Boston | Massachusetts | |
| Local Institution - 115 | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | |
| Local Institution - 110 | Boston | Massachusetts | |
| Local Institution - 104 | Ann Arbor | Michigan | |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Local Institution - 103 | Detroit | Michigan | |
| Local Institution - 140 | Grand Island | Nebraska | |
| Local Institution - 141 | Grand Island | Nebraska | |
| Local Institution - 137 | Omaha | Nebraska | |
| Local Institution - 138 | Omaha | Nebraska | |
| Local Institution - 131 | Omaha | Nebraska | |
| Local Institution - 139 | Papillion | Nebraska | |
| Local Institution - 756 | Cherry Hill | New Jersey | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| Local Institution - 108 | Hackensack | New Jersey | |
| Local Institution - 122 | Mineola | New York | |
| NYU Winthrop Hospital | Mineola | New York | |
| Local Institution - 121 | New York | New York | |
| New York University School of Medicine | New York | New York | |
| Icahn School of Medicine at Mount Sinai Medical Center | New York | New York | |
| Local Institution - 109 | New York | New York | |
| Local Institution - 111 | New York | New York | |
| New York Presbyterian Hospital Weil Cornell Medical College | New York | New York | |
| Local Institution - 125 | Rochester | New York |
+ 122 more sites — see the full list on the official registry below.
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02773030 on ClinicalTrials.gov ↗ ← All trials in Australia