Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03989414
Other study ID # CC-92480-MM-002
Secondary ID U1111-1233-56192
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 30, 2019
Est. completion date November 30, 2026

Study information

Verified date May 2024
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 424
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: - Documented diagnosis of multiple myeloma (MM) and measurable disease - Documented disease progression during or after their last antimyeloma regimen - Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen Exclusion Criteria: - Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis - Known central nervous system (CNS) involvement with myeloma - Received immunosuppressive medication within the last 14 days of initiating study treatment - Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CC-92480
Specified dose on specified days
Bortezomib
Specified dose on specified days
Dexamethasone
Specified dose on specified days
Daratumumab
Specified dose on specified days
Carfilzomib
Specified dose on specified days
Elotuzumab
Specified dose on specified days
Isatuximab
Specified dose on specified days
Carfilzomib
Specified dose on specified days

Locations

Country Name City State
Canada Local Institution - 201 Calgary Alberta
Canada Local Institution - 205 Edmonton Alberta
Canada Local Institution - 204 Halifax Nova Scotia
Canada Local Institution - 202 Montreal Quebec
Canada Local Institution - 203 Toronto Ontario
Czechia Local Institution - 802 Brno
Czechia Local Institution - 801 Ostrava-Poruba
Czechia Local Institution - 803 Praha 2
Denmark Local Institution - 902 Odense
Denmark Local Institution - 903 Vejle
France Local Institution - 703 Lille cedex
France Local Institution - 705 Marseille cedex
France Local Institution - 704 Nantes Cedex 01
France Local Institution - 701 Toulouse Cedex 9
France Local Institution - 702 Tours cedex
Germany Local Institution - 604 Freiburg
Germany Local Institution - 605 Hamburg
Germany Local Institution - 601 Heidelberg
Germany Local Institution - 602 Munchen
Germany Local Institution - 603 Wuerzburg
Greece Local Institution - 301 Athens
Italy Local Institution - 404 Brescia
Italy Local Institution - 401 Milan
Italy Local Institution - 403 Reggio Emilia
Italy Local Institution - 402 Torino
Spain Local Institution - 504 Badalona
Spain Local Institution - 501 Madrid
Spain Local Institution - 508 Madrid
Spain Local Institution - 506 Malaga
Spain Local Institution - 505 Pamplona
Spain Local Institution - 502 Salamanca
Spain Local Institution - 503 Santander
Spain Local Institution - 507 Valencia
United States Local Institution - 108 Atlanta Georgia
United States Local Institution - 101 Boston Massachusetts
United States Local Institution - 117 Boston Massachusetts
United States Local Institution - 118 Boston Massachusetts
United States Local Institution - 107 Chicago Illinois
United States Local Institution - 112 Chicago Illinois
United States Local Institution - 115 Columbus Ohio
United States Local Institution - 119 Denver Colorado
United States Local Institution - 113 Detroit Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Local Institution - 116 Houston Texas
United States Local Institution - 114 Nashville Tennessee
United States Local Institution - 106 Rochester Minnesota
United States Swedish Cancer Institute Seattle Washington
United States Local Institution - 104 Tampa Florida
United States Local Institution - 110 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended Dose Up to approximately 3 years
Primary Recommended regimen as measured by dose-limiting toxicities Up to approximately 3 years
Primary Number of participants with Adverse Events (AEs) From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
Primary Overall response rate (ORR) Up to approximately 5 years
Secondary Time-to-response (TTR) Up to approximately 5 years
Secondary Duration of response (DOR) Up to approximately 5 years
Secondary Complete Response (CR) rate Up to approximately 5 years
Secondary Very good partial response (VGPR) rate - Cohorts D and E Up to approximately 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1
Recruiting NCT04111809 - Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care