Phase
Condition
Multiple Myeloma
Bone Neoplasm
Lymphoproliferative Disorders
Treatment
Lenalidomide
Daratumumab
Elranatamab
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;
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 as defined by age ≥65 years or transplant-ineligible asdefined by age <65 years with comorbidities impacting the possibility of transplant
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, up to 4 days of 40 mg dexamethasone or equivalentbefore the first dose of study intervention).
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 Hospital
Richmond, Victoria 3121
AustraliaSite Not Available
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
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
Praha 2, 12808
CzechiaActive - Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne 31100
FranceSite Not Available
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093 Cedex 1
FranceActive - Recruiting
Universitaetsklinikum Tuebingen
Tübingen, Baden-württemberg 72076
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
University Hospital of Ioannina
Ioannina, Ípeiros 455 00
GreeceSite Not Available
Soroka Medical Center
Be'er Sheva, Hadarom 8410101
IsraelSite Not Available
Rabin Medical Center
Petah-Tikva, Hamerkaz 4910021
IsraelSite Not Available
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
Ramat Gan, Hamerkaz 5265601
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, Tell Abīb 6423906
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, Yerushalayim 9112001
IsraelActive - 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
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardia 20900
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Piemonte 10126
ItalySite Not Available
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicilia 90127
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana 56126
ItalySite Not Available
Istituto Europeo di Oncologia IRCCS
Milano, 20141
ItalyActive - Recruiting
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara, 65124
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalySite Not Available
University of Fukui Hospital
Eiheiji-cho,Yoshida-gun, Fukui 910-1193
JapanSite Not Available
University of Fukui Hospital
Yoshida-gun, Fukui 910-1193
JapanSite Not Available
Gunma University Hospital
Maebashi, Gunma 371-8511
JapanSite Not Available
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, Iwate 028-3695
JapanSite Not Available
Iwate Medical University Hospital
Yahaba-cho, Iwate 028-3695
JapanActive - Recruiting
Iwate Medical University Hospital
Yahaba-cho, Shiwa-gun, Iwate 028-3695
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanActive - Recruiting
Tohoku University Hospital
Sendai-shi, Miyagi 980-8574
JapanSite Not Available
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka 411-8777
JapanActive - Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
JapanSite Not Available
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo 150-8935
JapanSite Not Available
Kyushu University Hospital
Fukuoka, 812-8582
JapanActive - Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanSite Not Available
Osaka Metropolitan University Hospital
Osaka, 545-0051
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanActive - Recruiting
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
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, Zuid-holland 3318 AT
NetherlandsSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Dolnośląskie 50-367
PolandSite Not Available
MTZ Clinical Research Powered by Pratia
Warszawa, Mazowieckie 02-127
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdańsk, Pomorskie 80-214
PolandActive - Recruiting
Centrum Medyczne Pratia Poznań
Skorzewo, Wielkopolskie 60-185
PolandSite Not Available
Pratia Onkologia Katowice
Katowice, Śląskie 40-519
PolandSite Not Available
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 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
Pamplona, Navarra 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
China Medical University Hospital
Taichung, 404332
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanSite Not Available
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