A Safety, PK and Efficacy Study of CC-92480 in Combination With Dexamethasone 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: NCT03374085|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : May 7, 2020
This is an open-label, multi-center, international, Phase 1 study to assess the safety, PK/PD and preliminary efficacy of CC-92480 in combination with dexamethasone in subjects with RRMM.
RRMM patient previously treated with at least 3 prior regimens including lenalidomide or pomalidomide, a proteasome inhibitor and a CD38 antibody will be eligible.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-92480 Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Preliminary Efficacy of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||March 2, 2021|
|Estimated Study Completion Date :||March 2, 2021|
Experimental: Administration of CC-92480 and Dexamethasone
Escalating doses of CC-92480 in combination with a fixed dose of dexamethasone administered according to two different dosing schedules
- Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]Number of participants with AEs (Type, frequency, seriousness, severity and relationship of AEs to CC-92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs).
- Pharmacokinetics- AUC [ Time Frame: Up to approximately 28 days ]Area under the plasma concentration-time curve
- Pharmacokinetics- Cmax [ Time Frame: Up to approximately 28 days ]Maximal plasma concentration
- Pharmacokinetics- Tmax [ Time Frame: Up to approximately 28 days ]Time to Cmax
- Pharmacokinetics- t1/2 [ Time Frame: Up to approximately 28 days ]Terminal-phase elimination half-life
- Pharmacokinetics- CL/F [ Time Frame: Up to approximately 28 days ]Apparent total clearance of the drug from plasma after oral administration
- Pharmacokinetics- Vz/F [ Time Frame: Up to approximately 28 days ]Apparent volume of distribution during terminal phase after non-intravenous administration
- Maximum tolerated dose (MTD) [ Time Frame: Up to approximately 28 days ]The highest dose of CC-92480 in combination with dexamethasone associated acceptable safety and tolerability.
- Overall response rate (ORR) [ Time Frame: Up to approximately 3 years ]Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria
- Time to response (TTR) [ Time Frame: Up to approximately 3 years ]Time from 1st dose of CC-92480 to the first documentation of response ≥ PR.
- Duration of response (DOR) [ Time Frame: Up to approximately 3 years ]Time from the first documentation of response (≥ PR) to the first documentation of PD or death.
- Progression free survival [ Time Frame: Up to approximately 3 years ]Time from 1st dose of CC-92480 to the first occurrence of disease progression or death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374085
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Study Director:||Tsvetan Biyukov, MD||Celgene|