A Safety Study to Determine Dose and Tolerability of CC-220 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02773030|
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-220 Drug: Dexamethasone||Phase 1 Phase 2|
Subjects assigned to CC-220 monotherapy, who develop PD will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with IMWG criteria.
The starting dose of DEX will be 40 mg QD on Days 1, 8, 15 and 22 of each 28-day cycle for subjects who are ≤75 years of age. For subjects who are >75 years of age, the starting dose of DEX is 20 mg QD on Days 1, 8, 15 and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the Investigator's best judgement. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.
All subjects with a minimal response (MR) or better who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD will be followed for response assessment every 28 days until PD or a new myeloma regimen has been started.
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-220 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma|
|Actual Study Start Date :||October 14, 2016|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||May 14, 2022|
Experimental: Cohort A: CC-220 Monotherapy - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Experimental: Cohort B: CC-220 in combination with Dexamethasone - Part1
Experimental: Cohort C: CC-220 Monotherapy - Part 2
Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part2
- Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 1 year ]MTD is defined as the previous dose level where a Dose Limiting Toxicity (DLT) is observed in at least 2 subjects within the first cycle.
- Dose Limiting Toxicity (DLT) [ Time Frame: Approximately 1 year ]Number of participants with a DLT
- Establish Recommended Phase 2 doses (RP2Ds) [ Time Frame: Approximately 1 year ]RP2D is defined as the dose selected for the phase 2 portion of the trial.
- Adverse Events (AEs) [ Time Frame: Approximately 3 years ]Number of participants with adverse events
- Overall response rate (ORR) [ Time Frame: Approximately 3 years ]Will be calculated as the number of responders divided by the number of subjects in the Efficacy Evaluable (EE) Population.
- Time to Response (TTR) [ Time Frame: Approximately 3 years ]Is defined as the time from the first date of dosing of IP to the first date of documented response (PR or better).
- Duration of Response (DOR) [ Time Frame: Approximately 3 years ]Is defined as Time from the first documentation of response to the first documentation of Progressive disease (PD)
- Pharmacokinetics ‐AUC 0-τ [ Time Frame: Approximately 1 year ]Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
- Pharmacokinetics ‐Cmax [ Time Frame: Approximately 1 year ]Maximum plasma concentration of drug
- Pharmacokinetics ‐Tmax [ Time Frame: Approximately 1 year ]Time to Maximum plasma concentration of drug
- Pharmacokinetics ‐t1/2 [ Time Frame: Approximately 1 year ]Terminal-phase elimination half life
- Pharmacokinetics ‐CLss/F [ Time Frame: Approximately 1 year ]Apparent total plasma clearance when dosed daily
- Pharmacokinetics ‐Vss/F [ Time Frame: Approximately 1 year ]Apparent total volume of distribution at steady state when dosed orally
- Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
- Overall Survival [ Time Frame: Approximately 3 years ]Time from first dose of IP to death due to any cause
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): NCT02773030
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
Show 29 Study Locations
|Study Director:||Amine Bensmaine, MD||Celgene Corporation|