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.

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 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 recommended phase 2 dose (RP2D) is established in Part 1 in either Cohort A, Cohort B, Cohort E or Cohort F. The cohorts 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 and select non-invasive malignancies, 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:

532

Study ID:

NCT02773030

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 87 Locations for this study

See Locations Near You

Local Institution - 102
Scottsdale Arizona, 85259, United States
Local Institution - 107
Little Rock Arkansas, 72205, United States
Local Institution - 101
Atlanta Georgia, 30322, United States
Local Institution - 120
Chicago Illinois, 60611, United States
Local Institution - 113
Fairway Kansas, 66205, United States
Local Institution - 106
Baltimore Maryland, 21201, United States
Local Institution - 114
Boston Massachusetts, 02115, United States
Local Institution - 115
Boston Massachusetts, 02117, United States
Local Institution - 110
Boston Massachusetts, 02215, United States
Local Institution - 104
Ann Arbor Michigan, 48109, United States
Local Institution - 103
Detroit Michigan, 48201, United States
Local Institution - 140
Grand Island Nebraska, 68803, United States
Local Institution - 141
Grand Island Nebraska, 68803, United States
Local Institution - 137
Omaha Nebraska, 68114, United States
Local Institution - 138
Omaha Nebraska, 68124, United States
Local Institution - 131
Omaha Nebraska, 68130, United States
Local Institution - 139
Papillion Nebraska, 68046, United States
Local Institution - 756
Cherry Hill New Jersey, 08003, United States
Local Institution - 108
Hackensack New Jersey, 07601, United States
Local Institution - 122
Mineola New York, 11501, United States
Local Institution - 121
New York New York, 10016, United States
Local Institution - 109
New York New York, 10029, United States
Local Institution - 111
New York New York, 10065, United States
Local Institution - 125
Rochester New York, 14642, United States
Local Institution - 112
Charlotte North Carolina, 28204, United States
Local Institution - 117
Cleveland Ohio, 44195, United States
Local Institution - 124
Columbus Ohio, 43210, United States
Local Institution - 116
Philadelphia Pennsylvania, 19104, United States
Local Institution - 123
Greenville South Carolina, 29605, United States
Local Institution - 134
Memphis Tennessee, 38120, United States
Local Institution - 118
Dallas Texas, 75390, United States
Local Institution - 119
Salt Lake City Utah, 84112, United States
Local Institution - 126
Seattle Washington, 98109, United States
Local Institution - 132
Tacoma Washington, 98405, United States
Local Institution - 854
Adelaide South Australia, 5000, Australia
Local Institution - 852
Box Hill Victoria, 3128, Australia
Local Institution - 904
Calgary Alberta, T2N 4, Canada
Local Institution - 901
Vancouver British Columbia, V5Z 1, Canada
Local Institution - 902
Halifax Nova Scotia, B3H 1, Canada
Local Institution - 903
Montreal Quebec, H4A 3, Canada
Local Institution - 704
Lile Cedax , 59037, France
Local Institution - 701
Pessac , 33604, France
Local Institution - 703
Pierre Benite cedex , 69495, France
Local Institution - 702
Poitiers Cedex , 86021, France
Local Institution - 605
Dresden , 01307, Germany
Local Institution - 603
Dusseldorf , 40225, Germany
Local Institution - 604
Hamburg , 20246, Germany
Local Institution - 602
Heidelberg , 69120, Germany
Local Institution - 601
Tuebingen , 72076, Germany
Local Institution - 606
Wuerzburg , 97080, Germany
Local Institution - 751
Jerusalem Yerushalayim, 91031, Israel
Local Institution - 754
Tel Hashomer , 52620, Israel
Local Institution - 755
Tel-Aviv , 64239, Israel
Local Institution - 307
Meldola , 47014, Italy
Local Institution - 305
Pavia , 27100, Italy
Local Institution - 302
Reggio Emilia , 42100, Italy
Local Institution - 303
Rome , 00161, Italy
Local Institution - 301
Torino , 10126, Italy
Local Institution - 808
Matsuyama Ehime, 790-8, Japan
Local Institution - 805
Aomori , 030-8, Japan
Local Institution - 813
Hiroshima City , 730-8, Japan
Local Institution - 812
Isehara City, Kanagawa , 259-1, Japan
Local Institution - 809
Kamogawa , 296-8, Japan
Local Institution - 802
Kyoto-city , 602-8, Japan
Local Institution - 811
Nagasaki-shi , 85285, Japan
Local Institution - 810
Nagoya , 464-8, Japan
Local Institution - 801
Nagoya , 467-8, Japan
Local Institution - 815
Ogaki , 503-8, Japan
Local Institution - 804
Osaka , 545-8, Japan
Local Institution - 803
Sendai , 980-8, Japan
Local Institution - 806
Shinagawa-ku, Tokyo , 141-8, Japan
Local Institution - 814
Sunto-gun , 411-8, Japan
Local Institution - 807
Toyohashi , 441-8, Japan
Local Institution - 503
Amsterdam , 1081 , Netherlands
Local Institution - 504
Maastrich , 6202 , Netherlands
Local Institution - 501
Rotterdam , 3075 , Netherlands
Local Institution - 502
Utrecht , 3584 , Netherlands
Local Institution - 404
Badalona (Barcelona) , 08916, Spain
Local Institution - 401
Barcelona , 08035, Spain
Local Institution - 405
Barcelona , 08908, Spain
Local Institution - 408
Madrid , 28007, Spain
Local Institution - 407
Madrid , 28034, Spain
Local Institution - 402
Pamplona , 31008, Spain
Local Institution - 406
Valencia , 46017, Spain
Local Institution - 205
Birmingham , B15 2, United Kingdom
Local Institution - 202
Leeds , LS9 7, United Kingdom
Local Institution - 204
Oxford , OX4 6, United Kingdom
Local Institution - 201
Sutton , SM2 5, United Kingdom
Local Institution - 203
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

532

Study ID:

NCT02773030

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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