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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

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ClinicalTrials.gov Identifier: NCT03374085
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-92480 Drug: Dexamethasone Phase 1

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Study Type : Interventional  (Clinical Trial)
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 6, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 1, 2020


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




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.



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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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374085


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

Locations
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United States, California
City of Hope Cancer Center Recruiting
Duarte, California, United States, 91010-300
United States, Colorado
Colorado Blood Cancer Institute Not yet recruiting
Denver, Colorado, United States, 80218
United States, Georgia
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center The University of Texas Recruiting
Houston, Texas, United States, 77030
Canada, Alberta
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Denmark
Rigshospitalet University Hospital Recruiting
Copenhagen, Denmark, 2100
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Spain
Hospital Universitari Germans Trias i Pujol Can Ruti Recruiting
Badalona (Barcelona), Spain, 08916
Hospital 12 de Octobre Recruiting
Madrid, Spain, 28041
Clínica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
United Kingdom
University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing Recruiting
London, United Kingdom, NW1 2PG
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine Recruiting
Oxford, United Kingdom, 0X3 7LE
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Michael Pourdehnad, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03374085     History of Changes
Other Study ID Numbers: CC-92480-MM-001
U1111-1205-3650 ( Registry Identifier: WHO )
2017-001236-19 ( EudraCT Number )
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019

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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
CC-92480
Relapsed
Refractory

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors