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

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Medical Conditions
  • Multiple Myeloma
Primary Contact Details
Associate Director Clinical Trial Disclosure
1-888-260-1599
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03374085
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.

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.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : CC-92480, Drug : Dexamethasone

Study Arm Groups : Administration of CC-92480 and Dexamethasone, Administration of CC-92480 and Dexamethasone

Intervention Type
See Interventions above
Primary Outcome Measures
    Adverse Events (AEs); From enrollment until at least 28 days after completion of study treatment; Pharmacokinetics- AUC; Up to approximately 28 days; Pharmacokinetics- Cmax; Up to approximately 28 days; Pharmacokinetics- Tmax; Up to approximately 28 days; Pharmacokinetics- t1/2; Up to approximately 28 days; Pharmacokinetics- CL/F; Up to approximately 28 days; Pharmacokinetics- Vz/F; Up to approximately 28 days; Maximum tolerated dose (MTD); Up to approximately 28 days
Secondary Outcome Measures
    Overall response rate (ORR); Up to approximately 3 years; Time to response (TTR); Up to approximately 3 years; Duration of response (DOR); Up to approximately 3 years; Progression free survival; Up to approximately 3 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
80
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Oxford
0X3 7LE
London
NW1 2PG
Sutton
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Associate Director Clinical Trial Disclosure
1-888-260-1599
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, Denmark, Finland, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CC-92480-MM-001
Sponsor(s)
Celgene
Key Dates

Recruitment Start Date

Feb 2018

Recruitment End Date

Jan 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

01 Dec 2017

Date updated in source

13 Mar 2019