Clinical Trials /

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

NCT03374085

Description:

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (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.

Related Conditions:
  • Multiple Myeloma
  • Non-Secretory Plasma Cell Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03374085

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CC-92480-MM-001
  • SECONDARY ID: U1111-1205-3650
  • SECONDARY ID: 2017-001236-19
  • NCT ID: NCT03374085

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CC-92480Administration of CC-92480 and Dexamethasone
DexamethasoneAdministration of CC-92480 and Dexamethasone

Purpose

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. All eligible subjects must be refractory to their last line of therapy and have failed, be intolerant to or are not otherwise candidates for available therapies demonstrated to confer clinical benefit to subjects with relapsed and refractory multiple myeloma including (at a minimum), thalidomide, lenalidomide or pomalidomide and a proteasome inhibitor.

Trial Arms

NameTypeDescriptionInterventions
Administration of CC-92480 and DexamethasoneExperimentalEscalating doses of CC-92480 in combination with a fixed dose of dexamethasone administered according to two different dosing schedules
  • CC-92480
  • Dexamethasone

Eligibility Criteria

        Inclusion Criteria:

          1. Subject is ≥ 18 years of age and ECOG performance status score of 0, 1 or 2.

          2. Subjects must have measurable disease and documented disease progression on or within
             60 days from the last dose of their last myeloma therapy and have failed treatment
             with, are intolerant to or are not otherwise candidates for available therapies.

          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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events (AEs)
Time Frame:From enrollment until at least 28 days after completion of study treatment
Safety Issue:
Description: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).

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria
Measure:Time to response (TTR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Time from 1st dose of CC-92480 to the first documentation of response ≥ PR.
Measure:Duration of response (DOR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Time from the first documentation of response (≥ PR) to the first documentation of PD or death.
Measure:Progression free survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Time from 1st dose of CC-92480 to the first occurrence of disease progression or death from any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celgene

Trial Keywords

  • Multiple Myeloma
  • Safety
  • Efficacy
  • CC-92480
  • Relapsed
  • Refractory

Last Updated

March 13, 2019