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 101 Locations for this study

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Mayo Clinic
Scottsdale Arizona, 85259, United States More Info
Peter Bergsagel, Site 102
Contact
480-342-4800
The University of Arizona Cancer Center
Tucson Arizona, 85719, United States
Local Institution - 107
Little Rock Arkansas, 72205, 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 More Info
Seema Singhal, Site 120
Contact
312-695-4159
Loyola University Medical Center LUMC - Cardinal Bernardin Cancer Center CBCC
Maywood Illinois, 60153, United States
The University of Kansas - Clinical Research Center
Fairway Kansas, 66205, United States More Info
Al-Ola Abdallah, Site 113
Contact
913-588-6078
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
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 More Info
Andrew Branagan, Site 115
Contact
617-724-4000
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 More Info
Erica Campagnaro, Site 104
Contact
216-368-1176
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Jeffrey Zonder, Site 103
Contact
313-576-8730
"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
"Bergan"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Omaha Nebraska, 68124, United States More Info
Stefano Tarantolo, Site 138
Contact
402-334-4773
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Stefano Tarantolo, Site 131
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402-334-4773
"Papillion"- Oncology Hematology West, PC dba Nebraska Cancer Specialist
Papillion Nebraska, 68046, United States More Info
Stefano Tarantolo, Site 139
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402-334-4773
Local Institution - 756
Cherry Hill New Jersey, 08003, United States More Info
Site 756
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Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
David Siegel, Site 108
Contact
201-996-5900
Mount Sinai Brooklyn
Brooklyn New York, 11234, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States More Info
Marc Braunstein, Site 122
Contact
5166639500ext4606
The Blavatnik Family- Chelsea Medical Center at Mount Sinai
New York New York, 10011, United States
New York University School Of Medicine
New York New York, 10016, United States More Info
David Kaminetzky, Site 121
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Icahn School of Medicine at Mount Sinai Medical Center
New York New York, 10029, United States More Info
Sundar Jagannath, Site 109
Contact
212-241-7873
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 More Info
Brea Lipe, Site 125
Contact
585-276-5555
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Manisha Bhutani, Site 112
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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 More Info
Abdullah Khan, Site 124
Contact
614-293-6295
Local Institution - 116
Philadelphia Pennsylvania, 19104, United States
Local Institution - 123
Greenville South Carolina, 29605, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States More Info
Muhammad Raza, Site 134
Contact
000-000-0000
Local Institution - 118
Dallas Texas, 75390, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City Utah, 84112, United States More Info
Brian McClune, Site 119
Contact
612-625-7101
Northwest Medical Specialties PLLC
Bonney Lake Washington, 98391, United States
Northwest Medical Specialties PLLC
Federal Way Washington, 98003, United States
Northwest Medical Specialties PLLC
Gig Harbor Washington, 98332, United States
Northwest Medical Specialties PLLC
Puyallup Washington, 98373, United States
University of Washington-Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Andrew Cowan, Site 126
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Northwest Medical Specialties PLLC
Tacoma Washington, 98405, United States More Info
Jorge Chaves, Site 132
Contact
253-428-8750
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Westmead New South Wales, 2145, Australia
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Adelaide South Australia, 5000, Australia More Info
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Box Hill Victoria, 3128, Australia More Info
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Calgary Alberta, T2N 4, Canada More Info
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Vancouver British Columbia, V5Z 1, Canada More Info
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Halifax Nova Scotia, B3H 1, Canada More Info
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Montreal Quebec, H4A 3, Canada More Info
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Local Institution - 704
Lile Cedax , 59037, France More Info
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Pessac , 33604, France More Info
Site 701
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Local Institution - 703
Pierre Benite cedex , 69495, France More Info
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Poitiers Cedex , 86021, France More Info
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Local Institution - 605
Dresden , 01307, Germany More Info
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Local Institution - 603
Dusseldorf , 40225, Germany More Info
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Local Institution - 604
Hamburg , 20246, Germany More Info
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Heidelberg , 69120, Germany More Info
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Local Institution - 601
Tuebingen , 72076, Germany More Info
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Wuerzburg , 97080, Germany More Info
Site 606
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Local Institution - 751
Jerusalem Yerushalayim, 91031, Israel More Info
Site 751
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Local Institution - 753
Afula , 18341, Israel
Local Institution - 752
Haifa , 31096, Israel
Local Institution - 0905
Jerusalem , 91031, Israel
Local Institution - 757
Kfar Saba , 44281, Israel
Local Institution - 754
Tel Hashomer , 52620, Israel More Info
Site 754
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Local Institution - 755
Tel-Aviv , 64239, Israel More Info
Site 755
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Local Institution - 307
Meldola , 47014, Italy More Info
Site 307
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Local Institution - 306
Napoli , 80131, Italy
Local Institution - 305
Pavia , 27100, Italy More Info
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Reggio Emilia , 42100, Italy More Info
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Rome , 00161, Italy More Info
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Torino , 10126, Italy More Info
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Matsuyama Ehime, 790-8, Japan More Info
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Aomori , 030-8, Japan More Info
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Hiroshima City , 730-8, Japan More Info
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Isehara City, Kanagawa , 259-1, Japan More Info
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Local Institution - 809
Kamogawa , 296-8, Japan More Info
Site 809
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Local Institution - 802
Kyoto-city , 602-8, Japan
Local Institution - 811
Nagasaki-shi , 85285, Japan More Info
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Local Institution - 810
Nagoya , 464-8, Japan More Info
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Local Institution - 801
Nagoya , 467-8, Japan More Info
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Local Institution - 815
Ogaki , 503-8, Japan More Info
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Local Institution - 804
Osaka , 545-8, Japan More Info
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Local Institution - 803
Sendai , 980-8, Japan
Local Institution - 806
Shinagawa-ku, Tokyo , 141-8, Japan More Info
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Local Institution - 814
Sunto-gun , 411-8, Japan More Info
Site 814
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Local Institution - 807
Toyohashi , 441-8, Japan More Info
Site 807
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Local Institution - 503
Amsterdam , 1081 , Netherlands More Info
Site 503
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Local Institution - 504
Maastrich , 6202 , Netherlands More Info
Site 504
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Local Institution - 501
Rotterdam , 3075 , Netherlands
Local Institution - 502
Utrecht , 3584 , Netherlands More Info
Site 502
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Local Institution - 404
Badalona (Barcelona) , 08916, Spain More Info
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Local Institution - 401
Barcelona , 08035, Spain More Info
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Local Institution - 405
Barcelona , 08908, Spain More Info
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Local Institution - 408
Madrid , 28007, Spain More Info
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Local Institution - 407
Madrid , 28034, Spain More Info
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Local Institution - 402
Pamplona , 31008, Spain More Info
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Local Institution - 406
Valencia , 46017, Spain More Info
Site 406
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Local Institution - 205
Birmingham , B15 2, United Kingdom
Local Institution - 202
Leeds , LS9 7, United Kingdom More Info
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Local Institution - 204
Oxford , OX4 6, United Kingdom More Info
Site 204
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Local Institution - 201
Sutton , SM2 5, United Kingdom
Local Institution - 203
Sutton , SM2 5, United Kingdom More Info
Site 203
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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

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