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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374085
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : August 11, 2020
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.

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 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 : December 26, 2021
Estimated Study Completion Date : May 6, 2022


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.



Information from the National Library of Medicine

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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. 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.

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
Show Show 18 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Tsvetan Biyukov, MD Celgene
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03374085    
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: August 11, 2020
Last Verified: August 2020

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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
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