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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
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE February 6, 2018
Estimated Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, PK and Efficacy Study of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: CC-92480
    CC-92480
  • Drug: Dexamethasone
    Dexamethasone
Study Arms  ICMJE 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
Interventions:
  • Drug: CC-92480
  • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
80
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
120
Estimated Study Completion Date  ICMJE March 2, 2021
Estimated Primary Completion Date March 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is ≥ 18 years of age and ECOG performance status score of 0, 1 or 2
  2. All subjects must have:

    1. received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen),
    2. documented disease progression on or within 60 days from the last dose of their last myeloma therapy,
    3. in addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.
  3. Subjects must have adequate bone marrow, renal, liver, and cardiac function.
  4. Females of childbearing potential (FCBP) and male subjects must agree with the pregnancy prevention plan.

Exclusion Criteria:

  1. Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Subject has non- or oligosecretory multiple myeloma.
  3. Subject is unable or unwilling to undergo protocol required venous thromboembolism (VTE) prophylaxis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE Spain,   Canada,   Denmark,   Finland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374085
Other Study ID Numbers  ICMJE CC-92480-MM-001
U1111-1205-3650 ( Registry Identifier: WHO )
2017-001236-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tsvetan Biyukov, MD Celgene
PRS Account Celgene
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP