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Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM).

  • Clinicaltrials.gov identifier

    NCT04975997

  • Recruitment Status

    Not yet recruiting

  • First Posted

    July 26, 2021

  • Last update posted

    November 22, 2021

Study Description

Brief summary:

This is a multicenter, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-220
    Drug: Dexamethasone
    Drug: Daratumumab
    Drug: Daratumumab
    Drug: Dexamethasone
    Drug: Bortezomib
  • Phase: Phase 3

Detailed Description

This is a multicenter, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 742 participants will be randomized 1:1 between 2 treatment arms: Approximately 371 participants will be randomized to receive Treatment Arm A (IberDd) Approximately 371 participants will be randomized to receive Treatment Arm B (DVd) Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment. The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 730 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
  • Estimated Study Start Date: November 2021
  • Estimated Primary Completion Date: May 2024
  • Estimated Study Completion Date: December 2029

Arms and interventions

Arm Intervention/treatment
Experimental: CC-220 in combination with dexamethasone and daratumumab
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Drug: CC-220
Oral CC-220 1.6mg on Days 1 to 21 of a 28-day cycle

Drug: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Experimental: Daratumumab in combination with bortezomib and dexamethasone
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8 and 15 for Cycles 1 to 3, on Day 1 for Cycles 4 to 8, and on Day 1 for Cycle 9

Drug: Dexamethasone
Oral dexamethasone 20mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 for the first 8 bortezomib treatment cycles. For participants older than 75 years, underweight (BMI < 18.5), have poorly controlled diabetes, or prior intolerance/adverse event to steroid therapy, dexamethasone may be administered at a dose of 10 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12.

Drug: Bortezomib
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

Outcome Measures

  • Primary Outcome Measures: 1. Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]
    To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: Approximately 10 years ]
    To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).
  • 2. Minimal Residual Disease (MRD) negativity rate [ Time Frame: Approximately 1.5 years ]
    Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).
  • 3. Overall Response Rate (ORR) [ Time Frame: Less than 1 year ]
    Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.
  • 4. Time to response (TTR) [ Time Frame: Less than 1 year ]
    Time from randomization to the first documentation of response (PR or better).
  • 5. Duration of Response (DoR) [ Time Frame: Approximately 2 years ]
    Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
  • 6. Time to Progression (TTP) [ Time Frame: Less than 1 year ]
    The time from randomization to the first documented disease progression.
  • 7. Time to Next Treatment (TTNT) [ Time Frame: Approximately 1 year ]
    Time from randomization to the start of the next antimyeloma treatment.
  • 8. Progression-free Survival 2 (PFS2) [ Time Frame: Approximately 5 years ]
    Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.
  • 9. Safety [ Time Frame: Less than one month ]
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
  • 10. European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) [ Time Frame: Less than 1 year ]
    Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.
  • 11. European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) [ Time Frame: Less than 1 year ]
    EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.
  • 12. European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) [ Time Frame: Less than 1 year ]
    The EQ-5D-5L has 2 components: a descriptive system and a visual analogue scale (VAS). The instrument's descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

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: Participant is ≥ 18 years of age Participant has documented diagnosis of multiple myeloma (MM) and measurable disease: M-protein quantities ≥ 1 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP); or Light chain MM without measurable disease in serum or urine: serum free light chain (FLC) levels ≥ 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio Participant has received 1 to 2 prior lines of anti-myeloma therapy. Participant achieved a response (partial response [PR] or better) to at least 1 prior anti-myeloma regimen. Participant must have documented disease progression during or after their last anti-myeloma regimen. Prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled: Best response achieved during CD38-directed therapy was ≥ PR. Participant did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy. Participant did not discontinue CD38-directed therapy due to a related AE. Last dose of daratumumab was ≥ 3 months prior to randomization. Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled: Best response achieved during bortezomib therapy was at least a minimal response (MR). Participant did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Exclusion Criteria: Participant has any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,000/µL. Platelet count: < 75,000/µL for participants in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for participants in whom ≥ 50% of bone marrow nucleated cells are plasma cells Hemoglobin < 8 g/dL (< 4.9 mmol/L). Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 or requiring dialysis. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L). Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN). Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome. Participant has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. Participant has peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain. Participant has prior history of malignancies, other than MM. Participant with known central nervous system involvement with MM.

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Florida
Advent Health
Orlando

United States, Florida
Florida Cancer Specialists North Region Sarah Cannon Research
Saint Petersburg

United States, Georgia
Emory University
Atlanta

United States, Louisiana
Hematology-Oncology Clinic
Baton Rouge

United States, Maryland
Center for Cancer And Blood Disorders
Bethesda

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Massachusetts
UMASS Memorial Hospital
Worcester

United States, Missouri
HCA Midwest Health
Kansas City

United States, New Jersey
Summit Medical Group Overlook Oncology Center
Summit

United States, New York
NYU Winthrop Hospital
Mineola

United States, New York
New York University School of Medicine
New York

United States, New York
New York - Presbyterian/Weill Cornell Medical Center
New York

United States, Ohio
Cleveland Clinic - Taussig Cancer Institute
Cleveland

United States, Pennsylvania
West Penn Allegheny Lupus Center of Excellence
Pittsburgh

United States, Tennessee
Tennessee Oncology
Chattanooga

United States, Tennessee
Sarah Cannon Research Institute
Nashville

United States, Texas
UT Southwestern Simmons Cancer Center
Dallas

United States, Wisconsin
University Of Wisconsin
Madison

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, South Australia
Flinders Medical Centre, Dept Of Oncology
Bedford Park

Australia, Victoria
Monash Medical Centre
Clayton

Australia, Victoria
Epworth Hospital
East Melbourne

Australia, Victoria
The Alfred Hospital
Melbourne

Australia, Western Australia
Fiona Stanley Hospital
Murdoch

Australia, Western Australia
Perth Blood Institute
West Perth

Australia
Royal Prince Alfred Hospital
Camperdown

Australia
St Vincent's Hospital Melbourne
Fitzroy

Australia
The Canberra Hospital
Garran

Austria
Medical University of Graz
Graz

Austria
Innsbruck Medical University
Innsbruck

Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz

Austria
Universitatsklinik der PMU
Salzburg

Austria
University Hospital St. Poelten
St Polten

Austria
Medizinische Universitaet Wien
Vienna

Austria
Wilhelminenspital der Stadt Wien
Wien

Belgium
AZ Sint-Jan AV Brugge
Brugge

Belgium
Institut Jules Bordet
Brussel

Belgium
Cliniques Universitaires Saint-Luc
Bruxelles

Belgium
Centre Hospitalier Universitaire de Liege
Liege

Canada, Alberta
Tom Baker Cancer Centre
Calgary

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, British Columbia
BC Cancer Agency, Fraser Valley Center
Surrey

Canada, New Brunswick
Saint John Regional Hospital
Saint John

Canada, Newfoundland and Labrador
Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center
St John's

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax

Canada, Ontario
Hamilton Health Sciences Corporation
Hamilton

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

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

Canada, Quebec
The Ottawa Hospital - General Campus
Ottawa

Canada, Saskatchewan
University of Saskatchewan
Saskatoon

Canada
CHUQ
Quebec

China
Beijing Boren Hospital
Beijing

China
Peking University Third Hospital
Beijing

China
Peking Union Medical College Hospital
Beijing

China
First Hospital of Jilin University
Changchun

China
Beijing Chaoyang Hospital Capital Medical University
Chaoyang District

China
Guangdong General Hospital
Guangzhou

China
Sun Yat-sen University Cancer Center
Guangzhou

China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou City

China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang

China
The First Affiliated Hospital of Harbin Medical University
Harbin

China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing

China
Ruijin Hospital Shanghai Jiaotong University
Shanghai

China
Shengjing Hospital Of China Medical University
Shenyang

China
The First Affiliated Hospital of Soochow University
Suzhu

China
Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences
Tianjin

China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan

China
Xijing Hospital
Xian

China
Henan Cancer Hospital
Zhengzhou

Czechia
Fakultni Nemocnice Brno
Brno

Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba

Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague 2

Denmark
Aalborg Universitetshospital
Aalborg

Denmark
Aarhus University Hospital
Aarhus

Denmark
Odense University Hospital
Odense

Denmark
Sealand University Hospital
Roskilde

Finland
Helsinki University Central Hospital
Helsinki

Finland
Oulu University Hospital
Oulu

Finland
Turku University Hospital
Turku

France
CH Argenteuil Victor Dupouy
Argenteuil

France
Hopital Henri Mondor
Creteil

France
Centre Hospitalier Departemental de Vendee
La Roche -Sur-Yon - Cedex 9

France
CHRU de Lille France
Lille Cedex

France
CHU Montpellier- Hopital Lapeyronie
Montpellier Cedex 5

France
CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage
Nancy Cedex

France
CHRU Nantes
Nantes

France
Hopital Saint-Louis
Paris Cedex

France
Hopital Saint Antoine
Paris

France
CHU Bordeaux
Pessac

France
Centre Hospitalier Lyon-Sud
Pierre-Benite CEDEX

France
CHU La Miletrie
Poitiers Cedex

France
CHRU Rennes
Rennes

France
CLCC H BecquerelHematology
Rouen

France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9

Germany
Universitätsklinikum der RWTH Aachen
Aachen

Germany
Universitatsklinikum Erlangen
Erlangen

Germany
Klinikum der Johann Wolfgang Goethe Universitat
Frankfurt am Main

Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg

Germany
Asklepios Klinik St. Georg
Hamburg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
Universitaetsklinikum Muenster
Munster

Germany
Universitaetsklinikum Wuerzburg
Wuerzburg

Greece
Alexandra General Hospital of Athens
Athens

Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki

Ireland
Cork University Hospital
Cork

Ireland
Beaumont Hospital
Dublin 9

Ireland
St James Hospital
Dublin

Ireland
University Hospital Galway
Galway

Israel
Rambam Medical Center
Haifa

Israel
Hadassah Medical Center
Jerusalem

Israel
Tel Aviv Sourasky Medical Center
Tel Aviv

Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna

Italy
Università di Catania- Presidio Ospedaliero Ferrarotto
Catania

Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milano

Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milano

Italy
A.O.U. Maggiore della Carità
Novara

Italy
Azienda Ospedaliera di Padova
Padova

Italy
Fondazione IRCCS Policlinico San Matteo
Pavia

Italy
Azienda Ospedaliera Universitaria Pisana
Pisa

Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria

Italy
Arcispedale Santa Maria Nuova - AUSL Reggio Emilia
Reggio Emilia

Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma

Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo FG

Italy
Azienda Ospedaliera S Maria di Terni
Terni

Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine

Japan
Aomori Prefectural Central Hospital
Aomori

Japan
National Hospital Organization Kyushu Medical Center
Fukuoka

Japan
Kameda Medical Center
Kamogawa

Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto-City

Japan
Matsuyama Red Cross Hospital
Matsuyama

Japan
Aichi Cancer Center
Nagoya

Japan
Nagoya City University Hospital
Nagoya

Japan
Okayama Medical Center
Okayama

Japan
Kindai University Hospital
Osaka-Sayama

Japan
Osaka City University Hospital
Osaka

Japan
Sapporo Hokuyu Hospital
Sapporo

Japan
Tohoku University Hospital
Sendai

Japan
Japan Red Cross Medical Center
Shibuya-ku

Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo

Japan
Toyohashi Municipal Hospital
Toyohashi

Korea, Republic of
Kyungpook National University Hospital
Daegu

Korea, Republic of
National Cancer Center
Gyeonggi-do

Korea, Republic of
Hwasun Chonnam National University Hospital
Hwasun-gun

Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Asan Medical Center
Seoul

Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam

Netherlands
HagaZiekenhuis
Den Haag

Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht

Norway
Haukeland University Hospital
Bergen

Norway
Oslo Universitetssykehus HF Ulleval
Oslo

Norway
Trondheim university hospital
Trondheim

Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok

Poland
Uniwersytet Jagiellonski Collegium Medicum
Krakow

Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sacz

Poland
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan

Poland
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego
Walbrzych

Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warszawa

Poland
Uniwersytecki Szpital Kliniczny
Wroclaw

Portugal
Centro Hospital e Universitario de Coimbra
Coimbra

Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa

Portugal
Champalimaud Cancer Center
Lisboa

Portugal
Hospital Center of Lisbon North E.P.E - Hospital Pulido Valente
Lisboa

Portugal
Ipo Instituto Portugues De Oncologia Porto
Porto

Portugal
Centro Hospitalar de Sao Joao, EPE
Porto

Russian Federation
City Clinical Hospital 52
Moscow

Russian Federation
State Institution Hematological Research, Centre of Russian Academy of Medical Science
Moscow

Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow

Russian Federation
Novosibirsk State Medical University
Novosibirsk

Russian Federation
Pavlov First Saint Petersburg State Medical University
Saint-Petersburg

Spain
Hospital de la Santa Creu i Sant Pau
Barcelona

Spain
Hospital Universitario Vall D hebron - PPDS
Barcelona

Spain
Hospital Universitari Germans Trias i Pujol
Barcelona

Spain
Hospital San Pedro de Alcantara
Caceres

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital de La Princesa
Madrid

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid

Spain
Hospital Universitario Virgen de la Victoria
Malaga

Spain
Hospital Universitario Virgen de La Arrixaca
Murcia

Spain
Hospital Universitario Central de Asturias
Oviedo

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela

Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia

Spain
Hospital Universitario Miguel Servet
Zaragoza

Sweden
Medicinkliniken
Boras

Sweden
Sahlgrenska University Hospital Department of Hematology and Coagulation
Goteborg

Sweden
Helsingborg hospital
Helsingborg

Sweden
Lund University Hosptial
Lund

Switzerland
Kantonsspital Graubunden
Chur

Switzerland
Kantonsspital St. GallenBereich OnkologieHamatologie
St. Gallen

Taiwan
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital
Niao-Sung Hsiang Kaohsiung County

Taiwan
China Medical University Hospital
Taichung City

Taiwan
Taichung Veterans General Hospital
Taichung

Taiwan
National Cheng Kung University Hospital
Tainan, Taiana

Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist.

Taiwan
Taipei Veterans General Hospital
Taipei

Taiwan
Chang Gung Medical Foundation, Linkou Memorial Hospital
Taoyuan City

Turkey
Ankara University Medical Faculty
Ankara

Turkey
Dokuz Eylul University Medical Faculty
Balçova

Turkey
Gazi Universitesi
Besevler Ankara

Turkey
Ege University Medical Faculty
Izmir

Turkey
Erciyes University Medical Faculty
Kayseri

Turkey
Ondokuz Mayis University Medical Faculty
Samsun

United Kingdom
Belfast City Hospital
Belfast Northern Ireland

United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham

United Kingdom
Kent and Canterbury Hospital
Canterbury Kent

United Kingdom
Victoria Hospital Blackpool
Lancashire Blackpool

United Kingdom
Leicester Royal Infirmary
Leicester

United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London

United Kingdom
Guy's and St Thomas' Hospital - London
London

United Kingdom
Freeman Hospital
Newcastle upon Tyne

United Kingdom
Nottingham City Hospital
Nottingham

United Kingdom
Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre
Oxford

United Kingdom
Queen Alexandra Hospital - Portsmouth
Portsmouth

United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton

United Kingdom
Royal Cornwall Hospitals Trust
Truro

United Kingdom
New Cross Hospital
Wolverhampton

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04975997 History of Changes
  • Other Study ID Numbers: CC-220-MM-002, U1111-1260-2872, 2020-000431-49
  • First Posted: July 26, 2021 Key Record Dates
  • Last Update Posted: November 22, 2021
  • Last Verified: November 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: Iberdomide, CC-220, Daratumumab, Darzalex Faspro, Bortezomib, Velcade, Dexamethasone, MM, Multiple Myeloma, RRMM, CELMoD, Cereblon Modulators
  • Additional relevant 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