NCT03486067
Recruiting
April 3, 2018
April 28, 2022
Brief summary:
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
Arm | Intervention/treatment |
---|---|
Experimental: Administration of CC-93269 |
Drug: CC-93269 Specified dose on specified days |
Inclusion Criteria: History of multiple myeloma with relapsed and refractory disease Eastern Cooperative Oncology Group Performance Status of 0 or 1 Must have measurable disease as determined by the central laboratory Exclusion Criteria: Symptomatic central nervous system involvement of multiple myeloma Prior autologous stem cell transplant ≤ 3 months prior Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior History of concurrent second cancers requiring active, ongoing systemic treatment Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, Alabama
University of Alabama at Birmingham
Birmingham
United States, Alabama
University Of Alabama At Birmingham
Birmingham
United States, California
University of California San Francisco Medical Center
San Francisco
United States, Connecticut
Yale Cancer Center
New Haven
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta
United States, Massachusetts
Massachusetts General Hospital
Boston
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston
United States, Michigan
Henry Ford Medical Center - New Center One
Detroit
United States, New York
Icahn School of Medicine at Mount Sinai Mount Sinai West
New York
United States, Washington
Swedish Cancer Institute
Seattle
Germany
Universitatsklinikum Erlangen
Erlangen
Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg
Germany
Universitaetsklinikum Heidelberg
Heidelberg
Germany
University of Tubingen
Tuebingen
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola
Italy
Istituto Clinico Humanitas
Milan
Spain
Vall d´Hebron University Hospital
Barcelona
Spain
Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona
Spain
Hospital General Gregorio Maranon
Madrid
Spain
Clinica Universidad de Navarra
Pamplona
Spain
Hospital Universitario de Salamanca
Salamanca
Spain
Hospital Universtario Marques de Valdecilla
Santander
Spain
Hospital de la Fe
Valencia
Spain
Hospital Universitario Doctor Peset
Valencia
Sweden
Sahlgrenska University Hospital
Gothenborg
Sweden
Skanes Universitetssjukhus Lund
Lund
Sweden
Karolinska Universitetssjukhuset - Solna
Solna
Sweden
Akademiska Hospital Uppsala
Uppsala
Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb