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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501396-62-00 | Registry Identifier | CTIS Number |
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This study is researching an experimental drug called linvoseltamab, also called REGN5458.
Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).
This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.
This study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linvoseltamab | Experimental | Randomization 1:1 |
|
| Elotuzumab/Pomalidomide/Dexamethasone (EPd) | Active Comparator | Randomization 1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linvoseltamab | Drug | REGN5458 will be administered by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants | Up to approximatively 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS per IMWG response criteria determined by IRC in all participants | Up to approximatively 5 years | |
| Objective Response (OR) of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants | Up to approximatively 5 years |
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Key Inclusion Criteria:
Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.
Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
Life expectancy of at least 6 months
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles (UCLA) | Active, not recruiting | Los Angeles | California | 90095 | United States | |
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| Label | URL |
|---|---|
| Study Information Website | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Elotuzumab | Drug | Elotuzumab will be administered by IV infusion |
|
|
| Pomalidomide | Drug | Pomalidomide capsules will be administered by mouth (PO) |
|
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| Dexamethasone | Drug | Dexamethasone tablets/capsules will be administered PO and/or by IV infusion |
|
|
| OR of CR or better per IMWG response criteria as determined by IRC in all participants | Up to approximatively 5 years |
| Overall Survival (OS) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| OS in all participants | Up to approximatively 5 years |
| Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence of MRD negative status in all participants | Up to approximatively 5 years |
| Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies | The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain. | Baseline to week 12 |
| Mean change in the worst pain score measured by BPI-SF Item 3 in all participants | The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain. | Baseline to week 12 |
| Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence TEAEs in all participants | Up to approximatively 5 years |
| Severity of TEAEs in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Severity of TEAEs in all participants | Up to approximatively 5 years |
| Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence of AESI in all participants | Up to approximatively 5 years |
| Severity of AESI in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Severity AESI in all participants | Up to approximatively 5 years |
| Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence of SAE in all participants | Up to approximatively 5 years |
| Severity of SAE in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Severity of SAE in all participants | Up to approximatively 5 years |
| PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| PFS per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| OR of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants | Up to approximatively 5 years |
| OR of PR or better per IMWG response criteria as determined by the IRC in all participants | Up to approximatively 5 years |
| OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants | Up to approximatively 5 years |
| OR of VGPR or better per IMWG response criteria as determined by IRC in all participants | Up to approximatively 5 years |
| OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| OR of PR or better per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| OR of CR or better per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| DoR as per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| DoR as per IMWG response criteria as determined by the IRC in all participants | Up to approximatively 5 years |
| Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Duration of MRD negative status in the bone marrow in all participants | Up to approximatively 5 years |
| Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in all participants | Up to approximatively 5 years |
| Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in all participants | Up to approximatively 5 years |
| Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Concentration of linvoseltamab in the serum over time in all participants | Up to approximatively 5 years |
| Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence of ADAs in all participants | Up to approximatively 5 years |
| Titer of ADAs in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Titer of ADAs in all participants | Up to approximatively 5 years |
| Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies | Up to approximatively 5 years |
| Incidence of Nabs to linvoseltamab over time in all participants | Up to approximatively 5 years |
| Proportion of Pain Responders in participants previously exposed to CD38 antibodies | Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA). | At week 12 |
| Proportion of Pain Responders in all participants | Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA). | At week 12 |
| Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies | The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." | Baseline to week 12 |
| Change in patient-reported QoL, per EORTC QLQ-C30 in all participants | The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much." | Baseline to week 12 |
| Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies | The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems. | Baseline to week 12 |
| Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants | The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems. | Baseline to week 12 |
| Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies | The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe". The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF. | Baseline to week 12 |
| Patient-Reported Outcomes in PGIS in all participants | The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe". The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF. | Baseline to week 12 |
| Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change". The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF. | Baseline to week 12 |
| Patient-Reported Outcomes in PGIC in all participants | The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change". The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF. | Baseline to week 12 |
| Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies | The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline to week 12 |
| Change in patient-reported general health status per EQ-5D-5L in all participants | The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline to week 12 |
| University of Florida Division of Sponsored Programs |
| Withdrawn |
| Gainesville |
| Florida |
| 32611 |
| United States |
| University of Kentucky, Markey Cancer Center Clinical Research Organization | Active, not recruiting | Lexington | Kentucky | 40536 | United States |
| Norton Cancer Institute | Active, not recruiting | Louisville | Kentucky | 40207 | United States |
| Stony Brook University | Active, not recruiting | Stony Brook | New York | 11794 | United States |
| Levine Cancer Center | Active, not recruiting | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Withdrawn | Durham | North Carolina | 27705 | United States |
| Kaiser Permanente Northwest | Active, not recruiting | Portland | Oregon | 97227 | United States |
| MD Anderson Cancer Center | Active, not recruiting | Houston | Texas | 77030 | United States |
| University of Washington | Active, not recruiting | Seattle | Washington | 98195 | United States |
| Royal Prince Alfred Hospital | Active, not recruiting | Camperdown | New South Wales | 2050 | Australia |
| Royal North Shore Hospital | Active, not recruiting | St Leonards | New South Wales | 2065 | Australia |
| Icon Cancer Centre - Wesley | Active, not recruiting | Auchenflower | Queensland | 4066 | Australia |
| Royal Brisbane and Women's Hospital | Active, not recruiting | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Active, not recruiting | Adelaide | South Australia | 5000 | Australia |
| Royal Hobart Hospital | Active, not recruiting | Hobart | Tasmania | 7000 | Australia |
| Launceston General Hospital | Active, not recruiting | Launceston | Tasmania | 7250 | Australia |
| St Vincent's Hospital | Active, not recruiting | Fitzroy | Victoria | 3065 | Australia |
| University Hospital Geelong | Active, not recruiting | Geelong | Victoria | 3220 | Australia |
| Austin Hospital | Active, not recruiting | Heidelberg | Victoria | 3084 | Australia |
| One Clinical Research at Hollywood Private Hospital | Active, not recruiting | Nedlands | Western Australia | 6009 | Australia |
| Clinique Universitaire de Mont Godinne | Completed | Yvoir | Namur | 5530 | Belgium |
| AZ Delta Algemeen Ziekenhuis Delta | Active, not recruiting | Roeselare | West-Vlaanderen | 8800 | Belgium |
| Ziekenhuis Netwerk Antwerpen Stuivenberg | Active, not recruiting | Antwerp | 2060 | Belgium |
| Cliniques Universitaires Saint-Luc | Withdrawn | Brussels | 1200 | Belgium |
| IDOR - Sao Rafael Salvador Bahia | Active, not recruiting | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital Erasto Gaertner | Active, not recruiting | Curitiba | Paraná | 81520-060 | Brazil |
| Associacao Dr Bartholomeu Tacchini | Active, not recruiting | Bento Gonçalves | Rio Grande do Sul | 95700-084 | Brazil |
| Hospital de Clinicas de Porto Alegre | Active, not recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Centro Gaucho Integrado | Active, not recruiting | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Animi Unidade de Tratamento Oncologico | Active, not recruiting | Lages | Santa Catarina | 88501-001 | Brazil |
| Instituto Americas de Ensino e Pesquisa | Active, not recruiting | Rio de Janeiro | 22793-080 | Brazil |
| A Beneficencia Portuguesa de Sao Paulo, Oncology House | Active, not recruiting | São Paulo | 01321000 | Brazil |
| Instituto DOr de Pesquisa e Ensino | Active, not recruiting | São Paulo | 01401-002 | Brazil |
| AC Camargo Cancer Center | Active, not recruiting | São Paulo | 01509-010 | Brazil |
| Clinica Medica Sao Germano | Active, not recruiting | São Paulo | 04537-080 | Brazil |
| The Ottawa Hospital Cancer Centre | Active, not recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Active, not recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network-Princess Margaret Cancer Center | Active, not recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Hospital Clinico Universidad de Los Andes | Active, not recruiting | Santiago | Las Condes | 7620157 | Chile |
| Clinica Alemana de Santiago | Active, not recruiting | Santiago | Santiago Metropolitan | 6681920 | Chile |
| Fundacion Arturo Lopez Perez | Active, not recruiting | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Clinica UC San Carlos de Apoquindo | Active, not recruiting | Santiago | Santiago Metropolitan | 7550000 | Chile |
| Centro Oncologia de Precision Universidad Mayor | Active, not recruiting | Santiago | Santiago Metropolitan | 7560907 | Chile |
| Centro de Investigaciones Clinicas Vina del Mar | Active, not recruiting | Viña del Mar | Valparaiso | 2540488 | Chile |
| Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) | Active, not recruiting | Lyon | Auvergne-Rhone | 69008 | France |
| Centre Francois Magendie | Active, not recruiting | Pessac | Gironde | 33600 | France |
| Centre Hospitalier Universitaire de Lille | Withdrawn | Lille | Hauts-de-France | 59037 | France |
| Hopital Saint Louis, APHP | Completed | Paris | 75010 | France |
| Saint Antoine Hospital | Completed | Paris | 75571 | France |
| Institut Curie | Completed | Saint-Cloud | 92210 | France |
| Hopital Necker | Active, not recruiting | Paris | Île-de-France Region | 75015 | France |
| Gustave Roussy | Active, not recruiting | Villejuif | Île-de-France Region | 94800 | France |
| Medical Clinic II | Active, not recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitat zu Lubeck Neuromuskulares Zentrum | Active, not recruiting | Lübeck | Ratzeburger | 23538 | Germany |
| University Hospital Hamburg Eppendorf | Active, not recruiting | Hamburg | 20246 | Germany |
| University Hospital Leipzig - Hematology and Cellular Therapy | Withdrawn | Leipzig | 4103 | Germany |
| Rambam Health Care Campus | Active, not recruiting | Haifa | North | 3109601 | Israel |
| Lady Davis Carmel Medical Center | Active, not recruiting | Haifa | 3436212 | Israel |
| Shaare Zedek Medical Center | Active, not recruiting | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center | Active, not recruiting | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Active, not recruiting | Ramat Gan | 52621 | Israel |
| The Tel Aviv Sourasky Medical Center | Active, not recruiting | Tel Aviv | 64239 | Israel |
| IRCCS Casa Sollievo della Sofferenza | Active, not recruiting | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori | Active, not recruiting | Meldola | Forli-Cesena | 47014 | Italy |
| Ospedale Policlinico San Martino IRCCS | Active, not recruiting | Genoa | Genova | 16132 | Italy |
| Azienda Ospedaliera Nazionale SS - Antonio e Biagio e Cesare Arrigo | Active, not recruiting | Alessandria | Piedmont | 15121 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino | Active, not recruiting | Turin | Piedmont | 10126 | Italy |
| IRCCS Fondazione Piemontese Oncologica Candiolo | Active, not recruiting | Candiolo | Torino | 10060 | Italy |
| AOU Ospedali Riuniti di Ancona | Active, not recruiting | Ancona | 60126 | Italy |
| Policlinico S. Orsola- Malpighi | Withdrawn | Bologna | 40138 | Italy |
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" | Active, not recruiting | Catania | 95123 | Italy |
| Universita degli Studi di Pavia - Fondazione IRCCS Policlini | Active, not recruiting | Pavia | 27100 | Italy |
| Ospedale Santa Maria delle Croci | Active, not recruiting | Ravenna | 48121 | Italy |
| AUSL IRCCS OF Reggio Emilia - Clinical Study Location - | Active, not recruiting | Reggio Emilia | 42123 | Italy |
| Ospedale di Circolo e Fondazione Macchi Varese | Active, not recruiting | Varese | 21100 | Italy |
| Aichi Medial University Hospital | Recruiting | Nagakute | Aichi-ken | 480-1195 | Japan |
| Chiba Cancer Center | Recruiting | Chiba | Chiba | 260-8717 | Japan |
| Kameda General Hospital | Recruiting | Kamogawa | Chiba | 296-8602 | Japan |
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kurume University Hospital | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
| Ogaki Municipal Hospital | Recruiting | Ōgaki | Gifu | 503-8502 | Japan |
| Gunma University Hospital | Recruiting | Maebashi | Gunma | 371-8511 | Japan |
| NHO Shibukawa Medical Center | Recruiting | Shibukawa | Gunma | 377-0280 | Japan |
| Sapporo Hokuyu Hospital | Recruiting | Sapporo | Hokkaido | 003-0006 | Japan |
| Iwate Medical University Hospital | Recruiting | Yahaba | Iwate | 028-3694 | Japan |
| National Hospital Organization Kumamoto Medical Center | Recruiting | Kumamoto | Kumamoto | 860-0008 | Japan |
| National Hospital Organization Okayama Medical Center | Recruiting | Kita-ku | Okayama-ken | 701-1192 | Japan |
| Osaka University Hospital | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical University Hospital | Recruiting | Iruma-gun | Saitama | 350-0495 | Japan |
| Tokushima Prefectural Central Hospital | Recruiting | Tokushima | Tokushima | 770-8539 | Japan |
| Japanese Red Cross Medical Center | Recruiting | Shibuya-ku | Tokyo | 150-8935 | Japan |
| Yamanashi Prefectural Central Hospital | Recruiting | Kofu | Yamanashi | 400-8506 | Japan |
| Fukushima Medical University | Recruiting | Fukushima | 960-1295 | Japan |
| National Hospital Organization Sendai Medical Center | Recruiting | Sendai | 983-8520 | Japan |
| Radboudumc | Active, not recruiting | Nijmegen | Gelderland | 6500HB | Netherlands |
| Albert Schweitzer Hospital | Active, not recruiting | Dordrecht | South Holland | 3318 AT | Netherlands |
| University Clinical Center / Medical University of Gdansk | Active, not recruiting | Gdansk | Pomeranian Voivodeship | 80-219 | Poland |
| Szpital Uniwersytecki Nr2 Bydgoszcz | Completed | Bydgoszcz | 85-168 | Poland |
| Pratia Onkologia Katowice | Active, not recruiting | Katowice | 40-519 | Poland |
| Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Active, not recruiting | Lublin | 20-954 | Poland |
| Wielospecjalistyczne Centrum Onkologii i Traumatologii | Active, not recruiting | Lodz | Łódź Voivodeship | 93-510 | Poland |
| National University Hospital | Active, not recruiting | Singapore | 119074 | Singapore |
| Singapore General Hospital | Active, not recruiting | Singapore | 169608 | Singapore |
| Gachon University Gil Hospital | Active, not recruiting | Incheon | Gyeonggi-do | 21565 | South Korea |
| Jeonbuk National University Hospital | Active, not recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Chonnam National University Hwasun Hospital | Active, not recruiting | Hwasun | Jeollanam-do | 58128 | South Korea |
| Inje University Busan Paik Hospital | Active, not recruiting | Busan | 47392 | South Korea |
| Pusan National University Hospital | Active, not recruiting | Busan | 49241 | South Korea |
| Asan Medical Center | Active, not recruiting | Seoul | 05505 | South Korea |
| Seoul St Marys Hospital | Active, not recruiting | Seoul | 137-701 | South Korea |
| Samsung Medical Center | Active, not recruiting | Seoul | 6351 | South Korea |
| Seoul National University Hospital | Active, not recruiting | Seoul | 744 | South Korea |
| Severance Hospital | Active, not recruiting | Seoul | 82 | South Korea |
| Hospital Clinico Universitario Santiago de Compostela | Withdrawn | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitario Araba | Active, not recruiting | Vitoria-Gasteiz | Alava | 01009 | Spain |
| Hospital Universitari Son Espases | Active, not recruiting | Palma | Balearic Islands | 07120 | Spain |
| Hospital Universitari Son Llatzer | Active, not recruiting | Palma Mallorca | Balearic Islands | 07198 | Spain |
| Institut Catala d'Oncologia | Active, not recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari Mutua Terrassa | Active, not recruiting | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario Marques de Valdecilla | Active, not recruiting | Santander | Cantabria | 39008 | Spain |
| Complejo Asistencial Universitario de Leon | Active, not recruiting | León | Castille and León | 24070 | Spain |
| Hospital Universitario Puerta de Hierro | Withdrawn | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Quironsalud Madrid | Active, not recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universidad de Navarra - Pamplona | Withdrawn | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario de Navarra | Active, not recruiting | Pamplona | Navarre | 31008 | Spain |
| University Hospital of Cabuenes | Active, not recruiting | Gijón | Principality of Asturias | 33203 | Spain |
| Hospital Universitario Central de Asturias | Withdrawn | Oviedo | Principality of Asturias | 33011 | Spain |
| Universitary Hospital La Princesa | Active, not recruiting | Madrid | Salamanca | 28006 | Spain |
| Hospital General Universitario Doctor Balmis Alicante | Active, not recruiting | Alicante | Valencia | 03010 | Spain |
| Hospital Clinic de Barcelona | Active, not recruiting | Barcelona | 08036 | Spain |
| Hospital Sant Pau | Withdrawn | Barcelona | 08041 | Spain |
| Catalan Institute of Oncology (ICO) Hospitalet | Recruiting | Barcelona | 08908 | Spain |
| Instituto Catalan Oncologia | Active, not recruiting | Girona | 17007 | Spain |
| Clinica Universidad de Navarra - Madrid | Withdrawn | Madrid | 28027 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Active, not recruiting | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Active, not recruiting | Madrid | 28046 | Spain |
| Hospital Virgen de la Victoria | Active, not recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Valme | Active, not recruiting | Seville | 41014 | Spain |
| Hospital Universitari i Politecnic La Fe | Withdrawn | Valencia | 46026 | Spain |
| Hospital Clinico Lozano Blesa | Active, not recruiting | Zaragoza | 50009 | Spain |
| Chang Gung Memorial Hospital - Linkou Branch | Active, not recruiting | Taoyuan | Hunan Province | 33305 | Taiwan |
| Changhua Christian Hospital | Active, not recruiting | Changhua | 50006 | Taiwan |
| Hualien Tzu Chi Hospital | Active, not recruiting | Hualien City | 97002 | Taiwan |
| Kaohsiung Medical University Hospital | Active, not recruiting | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Active, not recruiting | Kaohsiung City | 83301 | Taiwan |
| Taichung Veterans General Hospital | Withdrawn | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Active, not recruiting | Tainan | 701 | Taiwan |
| Wanfang Hospital | Active, not recruiting | Taipei | 00116 | Taiwan |
| National Taiwan University Hospital | Active, not recruiting | Taipei | 10002 | Taiwan |
| Tri-Service General Hospital | Active, not recruiting | Taipei | 11490 | Taiwan |
| Addenbrooke's Hospital | Active, not recruiting | Cambridge | Cambrigeshire | CB2 0QQ | United Kingdom |
| Western General Hospital | Active, not recruiting | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Queen Elizabeth Hospital Birmingham | Active, not recruiting | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Barts Health NHS Trust | Active, not recruiting | London | EC1A 7BE | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust | Active, not recruiting | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | Active, not recruiting | London | SW7 3RP | United Kingdom |
| Hammersmith Hospital | Active, not recruiting | London | W12 0HS | United Kingdom |
| The Christie NHS Foundation Trust | Withdrawn | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C546027 | elotuzumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided