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

  • Clinicaltrials.gov identifier

    NCT02773030

  • Recruitment Status

    Recruiting

  • First Posted

    May 16, 2016

  • Last update posted

    August 4, 2021

Study Description

Brief 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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-220
    Drug: Dexamethasone
    Drug: Daratumumab - 16mg/kg
    Drug: Bortezomib (BTZ)
    Drug: Carfilzomib
    Drug: Daratumumab- 1800mg
  • Phase: Phase 1/Phase 2

Detailed Description

Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria. The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent. For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose. All subjects with a minimal response (MR) or better who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD. The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. The initiation of Part 2 will begin when the RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 464 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A 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
  • Actual Study Start Date: October 2016
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: October 2027

Arms and interventions

Arm Intervention/treatment
Experimental: Cohort A: CC-220 Monotherapy - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Drug: CC-220
CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Experimental: Cohort B: CC-220 in combination with Dexamethasone - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.
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.
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2
Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
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.
Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Intravenous DARA at dose 16mg/kg 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. Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at this dose level using SC DARA. Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes 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: 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 - 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: 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.
Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle. Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle. Subcutaneous BTZ at dose 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: 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: 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.
Experimental: Cohort G1-CC-220 in combination with CFZ and DEX -Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, 15 of each 28-day cycle Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg
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: 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.
Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 28-day cycle. The DEX dose will be 20 mg
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: 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.
Experimental: CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2
Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle 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: 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.
Experimental: CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2
Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above). Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle.
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: 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.
Experimental: CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2
Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle. Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.
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: 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.

Outcome Measures

  • Primary Outcome Measures: 1. Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
    Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
  • 2. Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment [ Time Frame: Approximately 1 year ]
    RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study.
  • 3. Overall response rate (ORR) of CC-220 in combination with DEX in Cohort D in Part 2 [ Time Frame: Approximately 3 years ]
    Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX
  • Secondary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
    Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
  • 2. Overall response rate (ORR) [ Time Frame: Approximately 3 years ]
    Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
  • 3. Time to Response (TTR) [ Time Frame: Approximately 3 years ]
    Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater).
  • 4. Duration of Response (DOR) [ Time Frame: Approximately 3 years ]
    Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
  • 5. Pharmacokinetics -AUC 0-τ [ Time Frame: Approximately 1 year ]
    Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
  • 6. Pharmacokinetics -Cmax [ Time Frame: Approximately 1 year ]
    Maximum plasma concentration of drug
  • 7. Pharmacokinetics -Tmax [ Time Frame: Approximately 1 year ]
    Time to Maximum plasma concentration of drug
  • 8. Pharmacokinetics -t1/2 [ Time Frame: Approximately 1 year ]
    Terminal-phase elimination half life
  • 9. Pharmacokinetics -CLss/F [ Time Frame: Approximately 1 year ]
    Apparent total plasma clearance when dosed daily
  • 10. Pharmacokinetics -Vss/F [ Time Frame: Approximately 1 year ]
    Apparent total volume of distribution at steady state when dosed orally
  • 11. Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]
    Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
  • 12. Overall Survival (OS) in Part 2 RRMM cohorts [ Time Frame: Approximately 3 years ]
    Time from first dose of IP to death due to any cause
  • 13. Very good partial response or better rate (VGPR) [ Time Frame: Approximately 4 years ]
    Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

United States, Arizona
Mayo Clinic
Scottsdale

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock

United States, Georgia
Winship Cancer Institute of Emory University
Atlanta

United States, Illinois
Robert H Lurie Comprehensive Cancer Center NW Univ
Chicago

United States, Kansas
University of Kansas Cancer Center
Fairway

United States, Maryland
University of Maryland School of Med
Baltimore

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Massachusetts
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor

United States, Michigan
Karmanos Cancer Institute
Detroit

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, New York
NYU Winthrop Hospital
Mineola

United States, New York
New York University School of Medicine
New York

United States, New York
Icahn School of Medicine at Mount Sinai Medical Center
New York

United States, New York
New York Presbyterian Hospital Weil Cornell Medical College
New York

United States, New York
University of Rochester Cancer Center
Rochester

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, Ohio
Cleveland Clinic Foundation
Cleveland

United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus

United States, Pennsylvania
University of Pennsylvania
Philadelphia

United States, South Carolina
Prisma Health Cancer Institute
Greenville

United States, Texas
University of Texas Southwestern Medical Center
Dallas

United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City

Canada, Alberta
Tom Baker Cancer Centre
Calgary

Canada, British Columbia
Vancouver General Hospital
Vancouver

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax

Canada, Quebec
McGill University Health Center - Royal Victoria Hospital
Montreal

France
CHRU Hopital Claude Huriez
Lile Cedax

France
CHU Bordeaux
Pessac

France
Centre Hospitalier Lyon Sud
Pierre Benite cedex

France
CHU La Miletrie
Poitiers Cedex

Germany
Medizinische Kinik und Poliklinik I
Dresden

Germany
Universitaetsklinikum Duesseldorf
Dusseldorf

Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
UKT Universitaetsklinikum Tuebingen
Tuebingen

Germany
Universitaets-klinikum Wuerzburg
Wuerzburg

Italy
I.R.C.C.S. Policlinico San Matteo - Universita di Pavia
Pavia

Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia

Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia
Rome

Italy
Osp. S.Giovanni Battista Le Molinette
Torino

Japan
Aomori Prefectural Central Hospital
Aomori

Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima City

Japan
Tokai University Hospital
Isehara City, Kanagawa

Japan
Kameda Medical Center
Kamogawa

Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city

Japan
Matsuyama Red Cross Hospital
Matsuyama

Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki-shi

Japan
Aichi Cancer Center
Nagoya

Japan
Nagoya City University Hospital
Nagoya

Japan
Ogaki Municipal Hospital
Ogaki

Japan
Osaka City University Hospital
Osaka

Japan
Tohoku University Hospital
Sendai

Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo

Japan
Shizuoka Cancer Center
Sunto-gun

Japan
Toyohashi Municipal Hospital
Toyohashi

Netherlands
VU University Medical Center
Amsterdam

Netherlands
Maastricht University Medical Center
Maastrich

Netherlands
Erasmus Medical Center
Rotterdam

Netherlands
University Medical Center Utrecht
Utrecht

Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona)

Spain
Hospital Val d'Hebron
Barcelona

Spain
Instituto Catalan de Oncologia-Hospital Duran i Reynals
Barcelona

Spain
Hospital Gregorio Maranon
Madrid

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Hospital Universitario Dr. Pesset
Valencia

United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham

United Kingdom
Saint James University Hospital
Leeds

United Kingdom
Genesis Care
Oxford

United Kingdom
The Institut of Cancer Research
Sutton

United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton

Sponsors and Collaborators

Celgene

Investigators

Study Director: April Sorrell-Taylor, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02773030 History of Changes
  • Other Study ID Numbers: CC-220-MM-001, U1111-1182-9200, 2016-000860-40
  • First Posted: May 16, 2016 Key Record Dates
  • Last Update Posted: August 4, 2021
  • Last Verified: August 2021
  • Keywords provided by Celgene: Bortezomib
    Daratumumab
    Dexamethasone
    Relapsed and refractory multiple myeloma
    CC-220
    Efficacy
    Safety
    Pharmacokinetics
    Refractory
    Relapsed
    Multiple Myeloma
  • Additional relevant MeSH terms: Neoplasms, Plasma Cell Multiple Myeloma