This service will be redeveloped soon — your feedback will help us to improve it.

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

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

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:

    Subjects must satisfy the following criteria to be enrolled in the study:

    1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).

    2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.

    3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

    4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

    5. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.

    6. Subjects must have the following laboratory values:

    - Absolute neutrophil count (ANC) ≥ 1.25 x 109/L without growth factor support for ≥ 7 days (≥ 14 days for pegfilgrastim).

    - Hemoglobin (Hgb) ≥ 8 g/dL.

    - Platelets (plt) ≥ 75 x 109/L without transfusion for ≥ 7 days (≥ 50 x 109/L for subjects with > 50% plasma cells in bone marrow).

    - Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).

    - 24-hr creatinine clearance (CrCl) ≥ 45 mL/min.

    - AST/SGOT and ALT/SGPT ≤ 3.0 x upper limit of normal (ULN).

    - Serum bilirubin ≤ 1.5 x ULN.

    - Uric acid ≤ 7.5 mg/dL (446 μmol/L).

    - PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).

    7. Females of childbearing potential (FCBP) must:

    1. Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after discontinuation of CC-92480. This applies even if the subject practices true abstinence* from heterosexual contact.

    2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, two reliable forms of contraception without interruption, 28 days prior to starting CC-92480, during the study therapy (including during dose interruptions), and for 28 days after discontinuation of study therapy.

    8. Male subjects must:

    Practice true abstinence (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 3 months following CC-92480 discontinuation, even if he has undergone a successful vasectomy.

    9. Males must agree to refrain from donating sperm while on CC-92480 and females must agree to refrain from donating ova while on CC-92480 for 90 days after its discontinuation.

    Exclusion Criteria:

    The presence of any of the following will exclude a subject from enrollment:

    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 any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

    3. Subject has any condition that confounds the ability to interpret data from the study.

    4. Subject has non- or oligosecretory multiple myeloma.

    5. Subject has plasma cell leukemia or active leptomeningeal myelomatosis.

    6. Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.

    7. Subject has immunoglobulin class M (IgM) myeloma.

    8. Subject has a history of allogeneic bone marrow transplantation.

    9. Subject is undergoing dialysis.

    10. Subjects with peripheral neuropathy ≥ Grade 2.

    11. Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.

    12. Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:

    - LVEF < 45% as determined by ECHO or MUGA scan at Screening.

    - Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening.

    - A prolongation of QT interval on Screening ECG; a history of or current risk factors for Torsades de Pointe; and concurrent administration of medications that prolong the QT/QTc interval.

    - Congestive heart failure (New York Heart Association Class III or IV).

    - Myocardial infarction ≤6 months prior to starting CC-92480.

    - Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.

    13. Concurrent administration of strong CYP3A modulators.

    14. Subject had prior systemic myeloma treatment within protocol defined period.

    15. Subject had major surgery ≤ 2 weeks prior to starting CC-92480.

    16. Subject is a pregnant or nursing female or intends to become pregnant during participation in the study.

    17. Subject has known human immunodeficiency virus (HIV) infection.

    18. Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection.

    19. Subject has a history of concurrent second cancer requiring ongoing systemic treatment.

    20. Subjects has a history of prior malignancy other than MM, unless the subject has been free of disease for ≥3 years except for noninvasive malignancies treated with curative intent.

    21. Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-92480 or dexamethasone.

    22. Subject has undergone either of the following within 14 days of initiating CC-92480:

    - Plasmapheresis.

    - Radiation therapy other than local therapy for symptomatic relief of MM associated bone lesions.

    23. Subject has received immunosuppressive medication within 14 days prior to the first dose of CC-92480.
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)
London
NW1 2PG
Sutton
Surrey
SM2 5PT
Oxford
0X3 7LE
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

23 Aug 2018