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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03486067
Recruitment Status Recruiting
First Posted April 3, 2018
Last update posted August 11, 2020
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered intravenously (IV), to determine the MTD and NTD of both the first dose and subsequent doses of CC-93269. The expansion part (Part B) will further evaluate the safety and efficacy of CC-93269 administered IV at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the RP2D. CC-93269, administered IV followed by subcutaneously (SC), will also be evaluated (Part C). 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 until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw.
|Experimental: Administration of CC-93269
CC-93269 by intravenous (IV) infusion or subcutaneous (SC) injection on a 28 day cycle.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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 a history of Multiple Myeloma (MM) with relapsed and refractory disease,
and must have failed treatment with, are intolerant to or are not candidates for
available therapies that are known to confer clinical benefit to patients with
relapsed and refractory MM.
4. Subjects must have measurable disease (as determined by the central lab).
5. Subject consents to hospitalization for monitoring and collection of study peripheral
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.
The presence of any of the following will exclude a subject from enrollment:
1. Unless otherwise specified, Subject has received prior investigational therapy
directed at B cell maturation antigen (BCMA). In selected cohort(s) of Parts A and B,
prior therapy directed at BCMA may be required for enrollment
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
7. Subject had a prior allogeneic stem cell transplant ≤ 12 month prior to starting
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)
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
15. Subject has a history or presence of clinically relevant central nervous system (CNS)
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. Inadequate pulmonary function.
20. Subject has active, uncontrolled, or suspected infection.
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 email@example.com
United States, Alabama
University of Alabama at Birmingham
United States, California
UCSF Medical Center
United States, Connecticut
Yale Cancer Center
United States, Georgia
Winship Cancer Institute of Emory University
United States, Michigan
Henry Ford Medical Center - New Center One
United States, Washington
Swedish Cancer Institute
Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato
University of Tubingen
Clinica Universitaria de Navarra
Hospital Universitario de Salamanca
Hospital Universtario Marques de Valdecilla
Hospital Universitario Doctor Peset
Skanes Universitetssjukhus Lund
Study Director: Michael R Burgess, MD, PhD Celgene