Multiple Myeloma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
Nonsecretory multiple myeloma
Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

449

Study ID:

NCT02773030

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 94 Locations for this study

See Locations Near You

Mayo Clinic
Scottsdale Arizona, 85259, United States
The University of Arizona Cancer Center
Tucson Arizona, 85719, United States More Info
Muhammad Husnain, Site 129
Contact
520-626-4555
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Sagar Lonial, Site 101
Contact
404-778-1900
Robert H Lurie Comprehensive Cancer Center NW Univ
Chicago Illinois, 60611, United States
Loyola University Medical Center LUMC - Cardinal Bernardin Cancer Center CBCC
Maywood Illinois, 60153, United States More Info
Patrick Hagen, Site 127
Contact
708-327-3346
Northwest Medical Specialists
Niles Illinois, 60714, United States More Info
Jorge Chaves, Site 132
Contact
253-428-8750
University of Kansas Cancer Center
Fairway Kansas, 66205, United States
University of Maryland School of Med
Baltimore Maryland, 21201, United States
University of Maryland School of Med
Baltimore Maryland, 21201, United States More Info
Ashraf Badros, Site 106
Contact
410-328-1230
Saint Agnes Hospital
Baltimore Maryland, 21229, United States More Info
Carole Miller, Site 133
Contact
667-234-2909
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States More Info
Jacalyn Rosenblatt, Site 114
Contact
617-667-9920
Massachusetts General Hospital
Boston Massachusetts, 02117, United States
Massachusetts General Hospital
Boston Massachusetts, 02117, United States More Info
Andrew Branagan, Site 115
Contact
617-724-4000
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston Massachusetts, 02215, United States
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston Massachusetts, 02215, United States More Info
Paul Richardson, Site 110
Contact
617-632-6624
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
"Grand Island"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island Nebraska, 68803, United States More Info
Stefano Tarantolo, Site 140
Contact
402-334-4773
"Regional" - Oncology Hematology West, PC dba Nebraska Cancer Specialist
Grand Island Nebraska, 68803, United States More Info
Stefano Tarantolo, Site 141
Contact
402-334-4773
"Methodist"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Omaha Nebraska, 68114, United States More Info
Stefano Tarantolo, Site 137
Contact
402-334-4773
Nebraska Cancer Specialists
Omaha Nebraska, 68114, United States More Info
Stefano Tarantolo, Site 131
Contact
402-334-4773
"Bergan"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Omaha Nebraska, 68124, United States More Info
Stefano Tarantolo, Site 138
Contact
402-334-4773
"Papillion"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Papillion Nebraska, 68046, United States More Info
Stefano Tarantolo, Site 139
Contact
402-334-4773
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Mount Sinai Brooklyn
Brooklyn New York, 11234, United States More Info
Sundar Jagannath, Site 136
Contact
212-241-7873
NYU Winthrop Hospital
Mineola New York, 11501, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai
New York New York, 10011, United States More Info
Sundar Jagannath, Site 135
Contact
212-241-7873
New York University School of Medicine
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai Medical Center
New York New York, 10029, United States
New York Presbyterian Hospital Weil Cornell Medical College
New York New York, 10065, United States
New York Presbyterian Hospital Weil Cornell Medical College
New York New York, 10065, United States More Info
Ruben Niesvizky, Site 111
Contact
646-258-0156
University of Rochester Cancer Center
Rochester New York, 14642, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Manisha Bhutani, Site 112
Contact
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Faiz Anwer, Site 117
Contact
520-694-8900
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Abdullah Khan, Site 124
Contact
614-293-6295
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Prisma Health Cancer Institute
Greenville South Carolina, 29605, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States More Info
Muhammad Raza, Site 134
Contact
000-000-0000
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City Utah, 84112, United States
Northwest Medical Specialties PLLC
Bonney Lake Washington, 98391, United States More Info
Jorge Chaves, Site 145
Contact
253-428-8750
Northwest Medical Specialties PLLC
Federal Way Washington, 98003, United States More Info
Jorge Chaves, Site 143
Contact
253-428-8750
Northwest Medical Specialties PLLC
Gig Harbor Washington, 98332, United States More Info
Jorge Chaves, Site 142
Contact
253-428-8750
Northwest Medical Specialties PLLC
Puyallup Washington, 98373, United States More Info
Jorge Chaves, Site 144
Contact
253-428-8750
University of Washington-Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Andrew Cowan, Site 126
Contact
Local Institution - 853
Westmead New South Wales, 2145, Australia More Info
Site 853
Contact
Local Institution - 854
Adelaide South Australia, 5000, Australia More Info
Site 854
Contact
Local Institution - 852
Box Hill Victoria, 3128, Australia More Info
Site 852
Contact
Local Institution - 904
Calgary Alberta, T2N 4, Canada More Info
Site 904
Contact
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Local Institution - 902
Halifax Nova Scotia, B3H 1, Canada More Info
Site 902
Contact
Queen Elizabeth II Health Sciences Centre
Halifax Nova Scotia, B3H 1, Canada
McGill University Health Center - Royal Victoria Hospital
Montreal Quebec, H4A 3, Canada
CHRU Hopital Claude Huriez
Lile Cedax , 59037, France
CHU Bordeaux
Pessac , 33604, France
Centre Hospitalier Lyon Sud
Pierre Benite cedex , 69495, France
CHU La Miletrie
Poitiers Cedex , 86021, France
Local Institution - 702
Poitiers Cedex , 86021, France More Info
Site 702
Contact
Medizinische Kinik und Poliklinik I
Dresden , 01307, Germany
Universitaetsklinikum Duesseldorf
Dusseldorf , 40225, Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg , 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
UKT Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Universitaets-klinikum Wuerzburg
Wuerzburg , 97080, Germany
Local Institution - 0905
Jerusalem , 91031, Israel
Local Institution - 307
Meldola , 47014, Italy More Info
Site 307
Contact
Local Institution - 306
Napoli , 80131, Italy More Info
Site 306
Contact
I.R.C.C.S. Policlinico San Matteo - Universita di Pavia
Pavia , 27100, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia , 42100, Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia
Rome , 00161, Italy
Osp. S.Giovanni Battista Le Molinette
Torino , 10126, Italy
Local Institution - 808
Matsuyama Ehime, 790-8, Japan More Info
Site 808
Contact
Local Institution - 814
Sunto-gun Shizuoka, 411-8, Japan More Info
Site 814
Contact
Aomori Prefectural Central Hospital
Aomori , 030-8, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima City , 730-8, Japan
Local Institution - 813
Hiroshima City , 730-8, Japan More Info
Site 813
Contact
Tokai University Hospital
Isehara City, Kanagawa , 259-1, Japan
Kameda Medical Center
Kamogawa , 296-8, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-city , 602-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki-shi , 85285, Japan
Aichi Cancer Center
Nagoya , 464-8, Japan
Local Institution - 801
Nagoya , 467-8, Japan More Info
Site 801
Contact
Nagoya City University Hospital
Nagoya , 467-8, Japan
Ogaki Municipal Hospital
Ogaki , 503-8, Japan
Local Institution - 804
Osaka , 545-8, Japan More Info
Site 804
Contact
Osaka City University Hospital
Osaka , 545-8, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Local Institution - 806
Shinagawa-ku, Tokyo , 141-8, Japan More Info
Site 806
Contact
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo , 141-8, Japan
Shizuoka Cancer Center
Sunto-gun , 411-8, Japan
Local Institution - 807
Toyohashi , 441-8, Japan More Info
Site 807
Contact
Toyohashi Municipal Hospital
Toyohashi , 441-8, Japan
VU University Medical Center
Amsterdam , 1081 , Netherlands
Maastricht University Medical Center
Maastrich , 6202 , Netherlands
Erasmus Medical Center
Rotterdam , 3075 , Netherlands
University Medical Center Utrecht
Utrecht , 3584 , Netherlands
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona) , 08916, Spain
Local Institution - 404
Badalona (Barcelona) , 08916, Spain More Info
Site 404
Contact
Hospital Val d'Hebron
Barcelona , 08035, Spain
Local Institution - 401
Barcelona , 08035, Spain More Info
Site 401
Contact
Instituto Catalan de Oncologia-Hospital Duran i Reynals
Barcelona , 08908, Spain
Local Institution - 405
Barcelona , 08908, Spain More Info
Site 405
Contact
Hospital Gregorio Maranon
Madrid , 28007, Spain
Local Institution - 408
Madrid , 28007, Spain More Info
Site 408
Contact
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Local Institution - 402
Pamplona , 31008, Spain More Info
Site 402
Contact
Hospital Universitario Dr. Pesset
Valencia , 46017, Spain
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom
Local Institution - 202
Leeds , LS9 7, United Kingdom More Info
Site 202
Contact
Saint James University Hospital
Leeds , LS9 7, United Kingdom
Genesis Care
Oxford , OX4 6, United Kingdom
The Institut of Cancer Research
Sutton , SM2 5, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

449

Study ID:

NCT02773030

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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