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NCT02773030

PHASE1/PHASE2

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

Sponsor: Celgene

View on ClinicalTrials.gov

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.

Official title: Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 As Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

466

Start Date

2016-10-14

Completion Date

2028-07-28

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

CC-220

CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

DRUG

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.

DRUG

Daratumumab

Specified dose on specified days

DRUG

Bortezomib

Specified dose on specified days

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Inclusion Criteria: 1\. All subjects in RRMM cohorts must have a documented diagnosis of Multiple Myeloma and have measurable disease defined as: 1. M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP ≥0.5 g/dL or uPEP ≥200 mg/24 hours and/or 2. Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio 2. All subjects in RRMM cohorts must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy. Subjects who had CAR T therapy as their last myeloma therapy must have documented disease progression. 3\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 3. Subject must have documented diagnosis with previously untreated symptomatic MM as defined by the criteria below (Rajkumar, 2016): MM diagnostic criteria; \- Clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma \- Any one or more of the following myeloma defining events: * One or more of the following myeloma-related organ dysfunction (at least one of the following); • \[C\] Calcium elevation (serum calcium \> 0.25 mmol/L \[\> 1 mg/dL\] higher than the upper limit of laboratory normal or \> 2.75 mmol/L \[\> 11 mg/dL\]) • \[R\] Renal insufficiency (serum creatinine \> 2 mg/dl \[\> 177 μmol/L\] or creatinine clearance \< 40 ml/min) * \[A\] Anemia (hemoglobin \< 10 g/dl or \> 2 g/dL below the lower limit of laboratory normal) * \[B\] Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)/CT * One or more of the following biomarkers of malignancy: * Clonal bone marrow plasma cell percentage\* ≥ 60% * Abnormal serum free light-chain (FLC) ratio ≥ 100 (involved kappa) or \<0.01 (involved lambda) and involved FLC level must be ≥ 100 mg/L * \>1 focal lesion detected by magnetic resonance imaging (MRI) (at least 5 mm in size) AND have measurable disease, as assessed by central laboratory, defined by any of the following: \- Immunoglobulin (Ig)G myeloma: serum M-protein level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours; or \- IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or \- Light chain multiple myeloma without measurable disease in serum or urine: serum FLC ≥ 100 mg/L and abnormal kappa lambda (κ/λ) ratio 4. Subjects in Cohort J1 are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation due to: \- Age ≥65 years, OR \- In subjects \<65 years: presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with autologous stem cell transplantation. 5\. Subjects in Cohort J2 are considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory data. Exclusion Criteria: 1\. Subject has nonsecretory multiple myeloma 2. Subjects with Plasma Cell leukemia or amyloidosis 3. Any of the following laboratory abnormalities • Absolute neutrophil count (ANC) \<1,000/μL • Platelet count \< 75,000/μL for Part 1. For Part 2; platelet count \< 75,000/μL for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count \< 50,000/μL (transfusions are not permitted to achieve minimum platelet counts • Corrected serum calcium \>13.5 mg/dL (\>3.4 mmol/L) * Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT)≥2.0 x upper limit of normal (ULN) * Serum total bilirubin and alkaline phosphatase \>1.5 x ULN * Subjects with serious renal impairment creatinine clearance (\[CrCl\] \<45 mL/min) or requiring dialysis would be excluded 4. Subjects with peripheral neuropathy ≥Grade 2

Locations (162)

Local Institution - 102

Scottsdale, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Local Institution - 107

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Local Institution - 101

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Local Institution - 120

Chicago, Illinois, United States

Robert H Lurie Comprehensive Cancer Center NW Univ

Chicago, Illinois, United States

Local Institution - 113

Fairway, Kansas, United States

University of Kansas Cancer Center

Fairway, Kansas, United States

Local Institution - 106

Baltimore, Maryland, United States

University of Maryland School of Med

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center