A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04036461|
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-99712||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, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||November 13, 2024|
|Estimated Study Completion Date :||November 13, 2024|
Experimental: Administration of CC-99712
CC-99712 will be administered via intravenous (IV) infusion once per 21-days on a Once every three weeks (Q3W) schedule, and once per 28-days on a Once every four weeks (Q4W) schedule
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 42 days after completion of study treatment ]Number of subjects with adverse event
- Non-Tolerated Dose (NTD) in subjects with relapsed and refractory MM [ Time Frame: Up to 28 days ]Is defined as the dose that causes DLTs in more than 33% of patient population during the first cycle of treatment.
- Maximum Tolerated Dose (MTD) in subjects with relapsed and refractory MM [ Time Frame: Up to 28 days ]Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.
- Dose Limiting Toxicity (DLT) in subjects with relapsed and refractory MM [ Time Frame: Up to 28 days ]Is defined as any of the following toxicities occurring within the DLT assessment window
- Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]Is defined as the proportion of subjects who achieve a partial response or better (eg, Partial response (PR), Very good partial response (VGPR), Complete response (CR) or sCR), according to IMWG response criteria.
- Time to Response [ Time Frame: Up to 3 years ]Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).
- Duration of Response [ Time Frame: Up to 3 years ]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 (PFS) [ Time Frame: Up to 3 years ]Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 3 years ]Is defined as the time from the first dose of CC-99712 to death from any cause.
- Pharmacokinetics- Cmax [ Time Frame: Up to 3 years ]Maximum plasma concentration of drug
- Pharmacokinetics- Cmin [ Time Frame: Up to 3 years ]Minimum plasma concentration of drug
- Pharmacokinetics- AUC [ Time Frame: Up to 3 years ]Area under the curve
- Pharmacokinetics- tmax [ Time Frame: Up to 3 years ]Time to peak (maximum) serum concentration
- Pharmacokinetics- t1/2 [ Time Frame: Up to 3 years ]Half-life
- Pharmacokinetics- CL [ Time Frame: Up to 3 years ]Clearance
- Pharmacokinetics- Vss [ Time Frame: Up to 3 years ]Volume of Distribution
- Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection [ Time Frame: Up to 3 years ]Anti-CC-99712 antibodies
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): NCT04036461
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|United States, California|
|University of California San Diego Moores Cancer Center||Not yet recruiting|
|La Jolla, California, United States, 92093|
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|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34232|
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|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|UT Southwestern Medical Center||Not yet recruiting|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Tom Baker Cancer Center||Not yet recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Princess Margaret Cancer Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal||Not yet recruiting|
|Montreal, Quebec, Canada, H1T 2M4|
|Study Director:||Kaida Wu, MD, PhD||Translational Development.|