Phase
Condition
Platelet Disorders
Lymphoproliferative Disorders
Bone Diseases
Treatment
Bortezomib
Dexamethasone
Lenalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al.,
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);
Urinary M-protein excretion ≥200 mg/24 hours;
Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa tolambda FLC ratio (<0.26 or >1.65).
Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who havereceived 1-2 prior lines of therapy including at least one immunomodulatory drug andone proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years ortransplant-ineligible as defined by age <65 years with comorbidities impacting thepossibility of transplant.
Part 2: participants with newly-diagnosed multiple myeloma that aretransplant-ineligible defined as:
Participants not considered candidates for high-dose chemotherapy and ASCT dueto age or
Participants with important comorbidities likely to have a negative impact ontolerability of high dose chemotherapy and ASCT.
ECOG performance status ≤2.
Not pregnant and willing to use contraception
For participants with RRMM: Resolved acute effects of any prior therapy to baselineseverity or CTCAE Grade ≤1.
Exclusion
Exclusion Criteria:
Smoldering Multiple Myeloma.
Monoclonal gammopathy of undetermined significance.
Waldenströms Macroglobulinemia
Plasma cell leukemia.
Active, uncontrolled bacterial, fungal, or viral infection, including (but notlimited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, carcinoma in situ, orStage 0/1 with minimal risk of recurrence per investigator.
For participants with RRMM: Previous treatment with a BCMA-directed therapy oranti-CD38-directed therapy within 6 months preceding the first dose of studyintervention in this study. Stem cell transplant ≤3 months prior to first dose ofstudy intervention or active GVHD.
For participants with NDMM: Previous systemic treatment for MM except for a shortcourse of corticosteroids (ie, total of 160 mg dexamethasone or equivalent beforethe first dose of study intervention). A cumulative dose of systemic corticosteroidsequivalent to ≥20 mg of dexamethasone during screening.
Live attenuated vaccine administered within 4 weeks of the first dose of studyintervention.
Administration of investigational product (eg, drug or vaccine) concurrent withstudy intervention or within 30 days (or as determined by the local requirement)preceding the first dose of study intervention used in this study.
Study Design
Connect with a study center
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Epworth Freemasons
Melbourne, Victoria 3002
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Epworth Healthcare
Richmond, Victoria 3121
AustraliaActive - Recruiting
Epworth Hospital
Richmond, Victoria 3121
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
Medizinische Universität Graz
Graz, Styria 8036
AustriaSite Not Available
Uniklinikum Salzburg
Salzburg, 5020
AustriaSite Not Available
Medizinische Universität Wien
Vienna, 1090
AustriaSite Not Available
Grand Hôpital de Charleroi
Gilly, Hainaut 6060
BelgiumSite Not Available
AZ Delta vzw
Roeselare, West-vlaanderen 8800
BelgiumActive - Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick E3B 5N5
CanadaSite Not Available
Nova Scotia Health Authority
Halifax, Nova Scotia B3S 0H6
CanadaActive - Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
CanadaActive - Recruiting
QEII Health Sciences Centre
Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality 100091
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510555
ChinaActive - Recruiting
Southern Medical University Nanfang Hospital
Guangzhou 1809858, Guangdong 1809935 510515
ChinaSite Not Available
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The first hospital of jilin university
Changchun, Jilin 130021
ChinaActive - Recruiting
Tongji University - Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality 200434
ChinaActive - Recruiting
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality 300020
ChinaActive - Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang 325000
ChinaActive - Recruiting
The first hospital of jilin university
Changchun 2038180, 130021
ChinaSite Not Available
Fakultní nemocnice Brno Bohunice
Brno, Brno-město 625 00
CzechiaActive - Recruiting
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezský KRAJ 708 52
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
CzechiaActive - Recruiting
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia 70210
FinlandActive - Recruiting
Turku University Hospital
Turku, Southwest Finland 20520
FinlandActive - Recruiting
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, 00029
FinlandActive - Recruiting
Oulu University Hospital
Oulu, 90220
FinlandActive - Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-maritimes 06200
FranceSite Not Available
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne 31100
FranceActive - Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093 Cedex 1
FranceActive - Recruiting
Hôpital Saint Antoine
Paris, 75012
FranceSite Not Available
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg 72076
GermanyActive - Recruiting
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg 89081
GermanySite Not Available
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate 55131
GermanyActive - Recruiting
Städtisches Klinikum Braunschweig
Braunschweig, 38114
GermanySite Not Available
Klinikum Chemnitz
Chemnitz, 09116
GermanyActive - Recruiting
Alexandra General Hospital of Athens
Athens, Attikí 115 28
GreeceActive - Recruiting
Evangelismos General Hospital of Athens
Athens, Attikí 106 76
GreeceActive - Recruiting
Evangelismos General Hospital of Athens
Athens 264371, Attikí 106 76
GreeceActive - Recruiting
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía 540 07
GreeceActive - Recruiting
University Hospital of Ioannina
Ioannina, Ípeiros 455 00
GreeceActive - Recruiting
Rabin Medical Center
Petah Tikva, Central District 4910021
IsraelActive - Recruiting
The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
Ramat Gan, Central District 5265601
IsraelActive - Recruiting
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
Ramat Gan, Central District 294904 5265601
IsraelSite Not Available
The Edmond and Lily Safra Children's HospitalnThe Chaim Sheba Medical CenternDepartment of Pediatric
Ramat Gan, Central District 294904 5265601
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, Jerusalem 9112001
IsraelActive - Recruiting
Soroka Medical Center
Beersheba, Southern District 8410101
IsraelActive - Recruiting
Sourasky Medical Center
Tel Aviv, TELL ABĪB 6423906
IsraelActive - Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola (Fc), Emilia-Romagna 47014
ItalyActive - Recruiting
AUSL di Piacenza
Piacenza, Emilia-Romagna 29121
ItalyActive - Recruiting
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna 48121
ItalyActive - Recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG 71013
ItalyActive - Recruiting
Cro-Irccs
Aviano, Friuli Venezia Giulia 33081
ItalyActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy 20900
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont 10126
ItalyActive - Recruiting
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily 90127
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany 56126
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
ItalyActive - Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
ItalyActive - Recruiting
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara, 65124
ItalyActive - Recruiting
Azienda Sanitaria Locale di Pescara
Pescara, 65124
ItalyActive - Recruiting
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara 3171168, 65124
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
University of Fukui Hospital
Yoshida-gun, Fukui 910-1193
JapanActive - Recruiting
Gunma University Hospital
Maebashi, Gunma 371-8511
JapanActive - Recruiting
Iwate Medical University Hospital
Yahaba-cho, Iwate 028-3695
JapanActive - Recruiting
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanActive - Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka 411-8777
JapanActive - Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
JapanActive - Recruiting
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo 150-8935
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
JapanActive - Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanActive - Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-0051
JapanActive - Recruiting
Yamagata University Hospital
Yamagata, 990-9585
JapanActive - Recruiting
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo 58128
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do 13620
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofActive - Recruiting
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland 3318 AT
NetherlandsActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship 50-367
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship 80-214
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdańsk, Pomorskie 80-214
PolandActive - Recruiting
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship 40-519
PolandSite Not Available
Centrum Medyczne Pratia Poznań
Skorzewo, Wielkopolskie 60-185
PolandActive - Recruiting
Auxilio Mutuo Cancer Center
San Juan, 00917
Puerto RicoSite Not Available
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo 58128
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do 13620
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South KoreaActive - Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul] 06591
South KoreaActive - Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul, Seoul-teukbyeolsi [seoul] 06591
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, Seoul-teukbyeolsi [seoul] 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul] 03080
South KoreaActive - Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul] 06591
South KoreaSite Not Available
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña] 15706
SpainActive - Recruiting
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona] 08916
SpainActive - Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908
SpainActive - Recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona [barcelona] 08221
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña] 08036
SpainActive - Recruiting
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [gerona] 17007
SpainActive - Recruiting
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de 28027
SpainActive - Recruiting
Clinica Universidad de Navarra
Madrid 3117735, Madrid, Comunidad de 28027
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre 31008
SpainActive - Recruiting
Hospital Universitario Doctor Peset
Valencia, València 46017
SpainActive - Recruiting
Hospital San Pedro de Alcántara
Cáceres, 10003
SpainActive - Recruiting
Hospital La Princesa
Madrid, 28006
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid 3117735, 28040
SpainActive - Recruiting
H.R.U Málaga - Hospital General
Málaga, 29010
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Kantonsspital Winterthur
Winterthur, 8401
SwitzerlandSite Not Available
China Medical University Hospital
Taichung, 404332
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 407
TaiwanActive - Recruiting
China Medical University Hospital
Taichung 1668399, 404332
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanActive - Recruiting
Leicester Royal Infirmary
Leicester, England LE1 5WW
United KingdomActive - Recruiting
Jupiter Medical Center/Anderson Family Cancer Institute
Jupiter, Florida 33458
United StatesSite Not Available
MSK Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
MSK Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
MSK Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
MSK Commack
Commack, New York 11725
United StatesActive - Recruiting
MSK Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York 10021
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York 10065
United StatesActive - Recruiting
MSK Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting

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