Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Determine the Recommended Dose and Regimen and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

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: NCT03989414
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-92480 Drug: Bortezomib Drug: Dexamethasone Drug: Daratumumab Drug: Carfilzomib Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 5, 2022
Estimated Study Completion Date : August 5, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: CC-92480 in combination with bortezomib and dexamethasone

Subjects in cohorts A, D and G will receive following:

  • Oral CC-92480 at specified cohort dose administered over a 21-day cycle
  • Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle
  • Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (>75 years old) administered over a 21-day cycle
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone

Experimental: CC-92480 in combination with daratumumab and dexamethasone

Subjects in cohorts B and E will receive following:

  • Oral CC-92480 at specified cohort dose administered over a 28-day cycle
  • Intravenous (IV) daratumumab 16 mg/kg administered over a 28-day cycle
  • Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Daratumumab
Daratumumab

Experimental: CC-92480 in combination with carfilzomib and dexamethasone

Subjects in cohort C and F will receive following:

  • Oral CC-92480 at specified cohort dose administered over a 28-day cycle
  • Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle
  • Oral/IV dexamethasone 40 mg/day administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Carfilzomib
Carfilzomib




Primary Outcome Measures :
  1. Dose-limiting Toxicities (DLT) [ Time Frame: UP to approximately 2 years from enrollment ]
    Number of participants with DLTs in the first cycle of the treatment

  2. Adverse Events (AEs) [ Time Frame: From first subject first visit until 28 days after the last subject discontinues study treatment. ]
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment

  3. Overall response rate (ORR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Defined as the proportion of subjects who achieve partial response (PR)or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria .


Secondary Outcome Measures :
  1. Time-to-response (TTR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Time from first dose to the first documentation of response (PR or greater)

  2. Duration of response (DOR) [ Time Frame: Up to approximately 3 years from enrollment ]
    Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death

  3. Complete Response (CR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria

  4. Very good partial response (VGPR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects is ≥ 18 years of age and has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  2. Relapsed or refractory subjects must have measurable disease and have documented disease progression during or after their last anti-myeloma regimen.
  3. Newly diagnosed subjects must have documented diagnosis with previously untreated symptomatic multiple myeloma.
  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 is unable or unwilling to undergo protocol required thromboembolism 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): NCT03989414


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Teresa Peluso, MD Celgene Corporation

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03989414     History of Changes
Other Study ID Numbers: CC-92480-MM-002
U1111-1233-5619 ( Other Identifier: WHO )
2018-004767-31 ( EudraCT Number )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Relapsed or Refractory Multiple Myeloma
Newly Diagnosed Multiple Myeloma
Multiple Myeloma
CC-92480
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Bortezomib
Daratumumab
BB 1101
Antibodies, Monoclonal
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