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NCT03486067
Recruiting
April 3, 2018
May 28, 2021
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 CC-93269 will be administered to each patient on a 28-day cycle |
Drug: CC-93269 CC-93269 |
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to
any study-related assessments/procedures being conducted.
2. Subject (male or female) is ≥ 18 years of age the time of signing the ICF.
3. Subject has non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's
macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal
protein, and skin changes) syndrome, or amyloidosis.
4. Subjects must have measurable disease (as determined by the central lab).
5. Subject consents to hospitalization for monitoring and collection of study peripheral
blood samples.
6. Subject consents to serial bone marrow aspirations and/or biopsies during Screening,
study treatment and at the end of treatment.
7. Subject has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
8. Subjects must have adequate hematologic, liver, renal, and coagulation function as
assessed by laboratory tests.
9. Females and males must practice true abstinence or agree to contraceptive methods
throughout the study, and during the safety follow-up period.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Subject has received prior therapy directed at B cell maturation antigen (BCMA).
2. Subject has symptomatic central nervous system involvement of multiple myeloma.
3. Subject has non-secretory multiple myeloma, plasma cell leukemia, Waldenstrom's
macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy,
monoclonal protein, and skin changes), or amyloidosis.
4. Subject is on chronic systemic immunosuppressive therapy or corticosteroids.
5. Subjects with clinically significant cardiac disease.
6. Subject had a prior autologous stem cell transplant ≤ 3 month prior to starting
CC-93269.
7. Subject had a prior allogeneic stem cell transplant ≤ 12 month prior to starting
CC-93269.
8. Subject had a prior systemic cancer-directed treatments or investigational modalities
≤ 5 half-lives or 4 weeks prior to starting CC-93269, whichever is shorter. Subjects
must have recovered from any clinically significant non-hematologic toxicities (ie, to
Grade ≤1) of prior systemic anti-cancer directed treatments unless otherwise specified
9. Subject had major surgery ≤ 2 weeks prior to starting CC-93269.
10. Subject is a pregnant or lactating female.
11. Subject has known history or serologic evidence of human immunodeficiency virus (HIV)
infection.
12. Subject has known history, virologic or serological evidence of hepatitis B or C virus
(HBV/HCV) infection. Subjects who had HCV but have received an antiviral treatment and
show no detectable HCV viral RNA for 6 months are eligible
13. Subject has a history of a venous thromboembolic event (VTE) within 6 months prior to
study entry (eg, deep-vein thrombosis or pulmonary embolism). Subjects with distant
history of VTE (ie, occurring > 6 months prior to study entry) who require ongoing
treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low
molecular weight heparin, Factor Xa inhibitors) are eligible for study entry.
14. Subject has a history of concurrent second cancers requiring active, ongoing systemic
treatment.
15. Subject has a history or presence of clinically relevant central nervous system (CNS)
pathology.
16. Subject has any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study.
17. Subject has any condition (eg, active or uncontrolled infection) including the
presence of laboratory abnormalities, which places the subject at unacceptable risk if
he/she were to participate in the study. .
18. Subject has any condition that confounds the ability to interpret data from the study.
19. Subject has inadequate pulmonary function.
20. Subject has active, uncontrolled, or suspected infection.
21. Subject has pulmonary, cardiac, or hepatic involvement of extramedullary multiple
myeloma.
22. Subjects with a history of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.
23. Recent SARS-CoV-2 vaccine as specified in the protocol.
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com
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, Massachusetts
Dana Farber Cancer Institute
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
Universitaetsklinik Hamburg - Eppendorf
Hamburg
Germany
Universitaetsklinikum Heidelberg
Heidelberg
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
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 Universitario Doctor Peset
Valencia
Sweden
Skanes Universitetssjukhus Lund
Lund
Sweden
Karolinska Universitetssjukhuset - Solna
Solna
Celgene
Study Director: Michael R Burgess, MD, PhD Celgene
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