Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03486067|
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-93269||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA X CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma.|
|Actual Study Start Date :||April 3, 2018|
|Estimated Primary Completion Date :||July 26, 2021|
|Estimated Study Completion Date :||June 16, 2022|
Experimental: Administration of CC-93269
CC-93269 by intravenous (IV) infusion on a 28 day cycle.
- Adverse Events (AEs) [ Time Frame: Up to 48 months ]Number of participants with Adverse Events
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to 48 months ]Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
- Non-Tolerated Dose (NTD) [ Time Frame: Up to 48 months ]Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 48 months ]Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
- Overall Response Rate (ORR) [ Time Frame: Up to 48 months ]Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.
- Time to Response [ Time Frame: Up to 48 months ]Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
- Duration of Response [ Time Frame: Up to 48 months ]Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
- Progression Free Survival [ Time Frame: Up to 48 months ]Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
- Overall Survival [ Time Frame: Up to 48 months ]Is defined as the time from the first dose of CC-93269 to death from any cause.
- Pharmacokinetics - Cmax [ Time Frame: Up to 48 months ]Maximum serum concentration of drug
- Pharmacokinetics - Cmin [ Time Frame: Up to 48 months ]Minimum serum concentration of drug
- Pharmacokinetics - AUC [ Time Frame: Up to 48 months ]Area under the curve
- Pharmacokinetics - tmax [ Time Frame: Up to 48 months ]Time to peak (maximum) serum concentration
- Pharmacokinetics - t1/2 [ Time Frame: Up to 48 months ]Terminal Half-life
- Pharmacokinetics - CL [ Time Frame: Up to 48 months ]Apparent total body clearance
- Pharmacokinetics - Vss [ Time Frame: Up to 48 months ]Volume of distribution at steady-state
- Pharmacokinetics - accumulation index of CC-93269 [ Time Frame: Up to 48 months ]Accumulation ratio of drug
- Presence and frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 48 months ]Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
- Evaluate measures of tumor sensitivity/ resistance to CC-93269 [ Time Frame: Up to 48 months ]Measurement of tumor and immune factors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486067
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCSF Medical Center||Recruiting|
|San Francisco, California, United States, 94143|
|United States, Michigan|
|Henry Ford Health System||Recruiting|
|Detroit, Michigan, United States, 48202|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98104|
|Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato||Not yet recruiting|
|Heidelberg, Germany, 69120|
|University of Tubingen||Not yet recruiting|
|Tübingen, Germany, 72076|
|Clinica Universitaria de Navarra||Recruiting|
|Pamplona, Spain, 31008|
|Hospital Universitario de Salamanca||Recruiting|
|Salamanca, Spain, 37007|
|Hospital Universtario Marques de Valdecilla||Recruiting|
|Santander, Spain, 39008|
|Hospital Universitario Doctor Peset||Recruiting|
|Valencia, Spain, 46017|
|Study Director:||Michael R Burgess, MD, PhD||Celgene|