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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)

  • Clinicaltrials.gov identifier

    NCT03989414

  • Recruitment Status

    Recruiting

  • First Posted

    June 18, 2019

  • Last update posted

    September 16, 2021

Study Description

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:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-92480
    Drug: Bortezomib
    Drug: Dexamethasone
    Drug: Daratumumab
    Drug: Carfilzomib
    Drug: Elotuzumab
    Drug: Isatuximab
    Drug: Carfilzomib
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 408 participants
  • Allocation: Non-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)
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: January 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
Oral CC-92480 at specified cohort A 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) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone
Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
Oral CC-92480 at specified cohort C 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 (20 mg/day for subjects > 75 years old) administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Carfilzomib
Carfilzomib
Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
Oral CC-92480 at RP2D 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) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle in the first 8 cycles and on days 1, 2, 8 and 9 after Cycle 8
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone
Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
Oral CC-92480 at RP2D 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 (20 mg/day for subjects > 75 years old) administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Carfilzomib
Carfilzomib
Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
Oral CC-92480 at RP2D administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle up to Cycle 6 Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle up to Cycle 6
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone
Experimental: Cohort H: CC-92480 with elotuzumab and dexamathasone
Oral CC-92480 at specified cohort H dose administered over a 28-day cycle Intravenous ELO 10 mg/kg then 20 mg/kg administered over a 28-day cycle Oral (28 mg) and IV (8 mg) dexamethasone for total 36 mg/day (oral [8 mg] and IV [8 mg] dexamethasone for total 16 mg/day for subjects > 75 years old) on ELO dosing days, and oral dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) on non-ELO dosing days, administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Elotuzumab
Elotuzumab
Experimental: Cohort I: CC-92480 with isatuximab and dexamathasone
Oral CC-92480 at specified cohort I dose administered over a 28-day cycle Intravenous ISA 10 mg/kg administered over a 28-day cycle Oral/IV dexamethasone 40 mg weekly (20 mg weekly for subjects > 75 years old)
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Isatuximab
Isatuximab
Experimental: Cohort J: CC-92480 with elotuzumab and dexamathasone
Oral CC-92480 at RP2D administered over a 28-day cycle Intravenous ELO 10 mg/kg then 20 mg/kg administered over a 28-day cycle Oral (28 mg)/IV (8 mg) dexamethasone for total 36 mg/day (oral [8 mg]/IV [8 mg] dexamethasone for total 16 mg/day for subjects > 75 years old) on ELO dosing days, and oral dexamethasone 40 mg/day (20 mg/day for subjects > 75 years old) on non-ELO dosing days, administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Elotuzumab
Elotuzumab
Experimental: Cohort K: CC-92480 with isatuximab and dexamathasone
Oral CC-92480 at RP2D administered over a 28-day cycle Intravenous ISA 10 mg/kg administered over a 28-day cycle Oral/IV dexamethasone 40 mg weekly (20 mg weekly for subjects > 75 years old)
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Isatuximab
Isatuximab
Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at specified cohort dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes 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: Subcohort B2: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at specified cohort dose administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Daratumumab
Daratumumab
Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at specified cohort B dose administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes 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: Subcohort E1: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at RP2D administered over a 28-day cycle Either IV DARA administered at a dose of 16 mg/kg or SC DARA administered at a dose of 1800 mg over 3 to 5 minutes 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: Subcohort E2: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at RP2D administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight, administered over a 21-day cycle from Cycle 1 to Cycle 8 and over a 28-day cycle from Cycle 9 onwards
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Daratumumab
Daratumumab
Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone
Oral CC-92480 at RP2D administered over a 28-day cycle Either Intravenous (IV) DARA administered at a dose of 16 mg/kg or Subcutaneous (SC) DARA administered at a dose of 1800 mg over 3 to 5 minutes 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

Outcome Measures

  • 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Key Inclusion criteria - Subject is ≥ to 18 years of age the time of signing the informed consent form (ICF). - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. For subjects in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: - Subject has documented diagnosis of MM and measurable disease, defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) and/or Serum free light chain (FLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable disease in the serum or urine - Subject has received 2 to 4 (for Cohorts A, B, C, H, and I) or 1 to 3 (Cohorts D, E, and F) or ≥ 2 (Cohorts J and K) prior anti-myeloma regimens. - Subject has received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles. - Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen. - Subject must have documented disease progression during or after their last anti-myeloma regimen. For Cohorts J and K: - Subject has also received prior treatment with a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) given alone or in combination for at least 2 consecutive cycles AND - Subject has failed therapy with lenalidomide and a proteasome inhibitor, given alone or in combination, defined as progression on or within 60 days of treatment, or disease progression within 6 months after achieving at least a partial response. Subject is refractory (progressed on or within 60 days of treatment) to their last treatment. - Cohort F: Prior therapy with a proteasome inhibitor (PI), excluding carfilzomib, is allowed as long as the subject had at least a PR to prior PI therapy, was not removed from PI therapy due to toxicity, and will have at least a 6-month PI treatment-free interval from last dose received until first study treatment (Subjects may receive maintenance therapy with drugs that are not in PI class during this 6-month treatment free interval). - For subjects in Cohort G, the following inclusions will also apply: Considered by the investigator to be eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT) according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory. Subject must have documented diagnosis with previously untreated symptomatic MM AND have measurable disease, as assessed by central laboratory. Exclusion Criteria: Key Exclusion criteria - Subject has any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) < 1,000/µL (for Phase 1 without growth factor support for ≥ 7 days [≥ 14 days for pegfilgrastim]) 2. Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to reach this level) 3. Hemoglobin < 8 g/dL (< 4.9 mmol/L) 4. Creatinine clearance (CrCl) < 45 mL/min (< 30 mL/min for Cohort G) 5. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) 6. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN 7. Serum total bilirubin > 1.5 x ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome 8. Prothrombin time (PT)/international normalized ratio (INR) 1.5 x ULN or partial thromboplastin time (PTT) 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation). - Subject has peripheral neuropathy ≥ Grade 2 - Subject with gastrointestinal disease that may significantly alter the absorption of CC-92480. - Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. - Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis. - Subject with known central nervous system (CNS) involvement with myeloma. - Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. The following are exceptions to this criterion: Intranasal, inhaled, topical or local corticosteroid injections (eg, intra-articular injection). - Systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or the equivalent. - Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication). - Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following: 1. Left ventricular ejection fraction (LVEF) < 45% as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at Screening. Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiogram (ECG) finding at Screening 2. A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval > 470 milliseconds (msec) using Fridericia's QT correction formula; a history of or current risk factors for torsades de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval Congestive heart failure (New York Heart Association Class III or IV). 3. Myocardial infarction within 12 months prior to starting study treatment. Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris 4. History of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, pericardial disease or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker 5. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment. 6. Concurrent administration of strong CYP3A modulators; concurrent administration of proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480. - Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study. Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C. - Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide, BTZ (for Cohorts A, D and G), DARA (for Cohorts B and E), CFZ (for Cohorts C and F), ELO (for Cohorts H and J), ISA (for Cohorts I and K), or dexamethasone. - Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-92480, BTZ (for Cohorts A, D and G), DARA (for Cohorts B and E), CFZ (for Cohorts C and F), ELO (for Cohorts H and J), ISA (for Cohorts I and K), or dexamethasone. - Contraindications to the standard treatment regimens, per local prescribing information. - Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis. For subjects in Cohorts A, B, C, D, E, F, H, I, J, and K, the following exclusions will also apply: - Subject received any of the following within the last 14 days of initiating study treatment: 1. Plasmapheresis 2. Major surgery (as defined by the Investigator) 3. Radiation therapy other than local therapy for myeloma associated bone lesions 4. Use of any systemic anti-myeloma drug therapy 5. Cohorts A and D: Subjects who had progression during treatment or within 60 days of the last dose of BTZ or discontinued BTZ due to toxicity. 6. Cohorts B and I: Subjects who had progression during treatment or within 60 days of the last dose of DARA/ISA or discontinued DARA/ISA due to toxicity. 7. Cohort C: Subjects who had progression during treatment or within 60 days of the last dose of CFZ or discontinued CFZ due to toxicity. 8. Cohorts D, E, F, J, and K: Previous treatment with pomalidomide (POM). 9. Cohorts E and K: Previous treatment with DARA or ISA. 10. Cohort F: Previous treatment with CFZ. 11. Subject used any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment. 12. Subject has received previous allogeneic stem cell transplantation or received autologous stem cell transplantation within 12 weeks prior to starting study treatment. 13. Cohorts B, E, I, and K: Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. Note that forced expiratory testing (FEV1) is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is < 50% of predicted normal. 14. Cohorts B, E, I, and K: Subject has known moderate or severe persistent asthma, or currently has uncontrolled asthma of any classification. 15. Cohorts C and F: Subject has mild hepatic impairment defined as elevated bilirubin 1.0 but < 1.5 x ULN or normal bilirubin with any elevation of AST. 16. Cohort H: Subjects who had progression during treatment or within 60 days of the last dose of ELO or discontinued ELO due to toxicity 17. Cohort J: Previous treatment with ELO For subjects in Cohort G, the following exclusion criteria will also apply: - Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of initiating study treatment]). For subjects in all cohorts: - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days for mild or asymptomatic infections or within 28 days for severe/critical illness prior to enrollment. - Acute symptoms must have resolved and there must be no sequelae that would place the subject at a higher risk of clinically significant complications from receiving study treatment, based on the Investigator's assessment in consultation with the Sponsor Medical Monitor.

Contacts and Locations

Contacts

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

Locations

United States, Colorado
Colorado Blood Cancer Institute
Denver

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa

United States, Georgia
Winship Cancer Institute of Emory University
Atlanta

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago

United States, Illinois
University of Chicago Medicine
Chicago

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Massachusetts
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Michigan
Barbara Ann Karmanos Cancer Center
Detroit

United States, Minnesota
Mayo Clinic
Rochester

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem

United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus

United States, Tennessee
Sarah Cannon Cancer Center
Nashville

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Washington
Swedish Cancer Institute
Seattle

Canada, Alberta
Tom Baker Cancer Center
Calgary

Canada, Alberta
University of Alberta - Faculty of Medicine and Dentistry
Edmonton

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal

Czechia
Fakultni Nemocnice Brno
Brno

Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba

Czechia
Charles University General Hospital
Praha 2

Denmark
Odense University Hospital
Odense

Denmark
Vejle Hospital
Vejle

France
Hopital Claude Huriez CHRU Lille
Lille cedex

France
Institut Paoli Calmette Hematologie
Marseille cedex

France
Hotel Dieu CHU Nantes
Nantes Cedex 01

France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse Cedex 9

France
CHRU Hopital Bretonneau
Tours cedex

Germany
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin

Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
Freiburg

Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen

Germany
Universitaets-klinikum Wuerzburg
Wuerzburg

Greece
Alexandra General Hospital of Athens
Athens

Italy
ASST Spedali Civili P.O. di Brescia
Brescia

Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan

Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia

Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino

Spain
Hopsital Germans Trias I Pujol
Badalona

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Hospital Universitario Virgen de la Victoria
Malaga

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Spain
Hospital Universtario Marques de Valdecilla
Santander

Spain
Hospital Universitario y Politecnico La Fe
Valencia

Sponsors and Collaborators

Celgene

Investigators

Study Director: Alessandro Ghiddi, MD Celgene

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03989414 History of Changes
  • Other Study ID Numbers: CC-92480-MM-002, U1111-1233-5619, 2018-004767-31
  • First Posted: June 18, 2019 Key Record Dates
  • Last Update Posted: September 16, 2021
  • Last Verified: September 2021
  • 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/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: CC-92480
    Multiple Myeloma
    Newly Diagnosed Multiple Myeloma
    Relapsed or Refractory Multiple Myeloma
  • Additional relevant MeSH terms: Neoplasms, Plasma Cell Multiple Myeloma