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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/04/2020.

A Safety, PK and Efficacy Study of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Clinicaltrials.gov identifier NCT03374085

Recruitment Status Recruiting

First Posted December 15, 2017

Last update posted August 11, 2020

Study Description

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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-92480
    Drug: Dexamethasone
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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 2018
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/treatment
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
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • 2. Pharmacokinetics- AUC [ Time Frame: Up to approximately 28 days ]
    Area under the plasma concentration-time curve
  • 3. Pharmacokinetics- Cmax [ Time Frame: Up to approximately 28 days ]
    Maximal plasma concentration
  • 4. Pharmacokinetics- Tmax [ Time Frame: Up to approximately 28 days ]
    Time to Cmax
  • 5. Pharmacokinetics- t1/2 [ Time Frame: Up to approximately 28 days ]
    Terminal-phase elimination half-life
  • 6. Pharmacokinetics- CL/F [ Time Frame: Up to approximately 28 days ]
    Apparent total clearance of the drug from plasma after oral administration
  • 7. Pharmacokinetics- Vz/F [ Time Frame: Up to approximately 28 days ]
    Apparent volume of distribution during terminal phase after non-intravenous administration
  • 8. 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.
  • Secondary Outcome Measures: 1. Overall response rate (ORR) [ Time Frame: Up to approximately 3 years ]
    Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria
  • 2. 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.
  • 3. 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.
  • 4. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 18 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Director: Tsvetan Biyukov, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03374085 History of Changes
  • Other Study ID Numbers: CC-92480-MM-001, U1111-1205-3650, 2017-001236-19
  • First Posted: December 15, 2017 Key Record Dates
  • Last Update Posted: August 11, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Multiple Myeloma
    Safety
    Efficacy
    Relapsed
    Refractory
    CC-92480
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell