A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Study Details
Study Description
Brief Summary
A study designed to evaluate the safety and efficacy of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1 VenDex Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle. |
Drug: Dexamethasone
oral, locally available form
Drug: Venetoclax
tablet; oral
Other Names:
|
Active Comparator: Arm 2 PomDex Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle. |
Drug: Pomalidomide
capsule, oral
Other Names:
Drug: Dexamethasone
oral, locally available form
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) [Up to approximately 43 months from first randomization]
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Secondary Outcome Measures
- Overall Response Rate (ORR) [Up to approximately 43 months from first randomization]
ORR is defined as the proportion of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
- Very Good Partial Response or Better Response Rate (VGPR) [Up to approximately 43 months from first randomization]
VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
- Overall survival (OS) [Up to approximately 51 months from first randomization]
OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
- Minimal Residual Disease (MRD) Negativity Rate [Up to approximately 43 months from first randomization]
MRD defined as the proportion of participants with MRD negativity status. MRD negativity will be defined at 10^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).
- Time to Deterioration in Disease Symptoms [Up to approximately 51 months from first randomization]
Time to deterioration in disease symptoms is measured by the disease symptom domain of the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20).
- Time to Deterioration in Physical Functioning [Up to approximately 51 months from first randomization]
Time to deterioration in physical functioning is measured by the physical functioning domain of European Organization for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).
- Change from Baseline in PROMIS Fatigue Score [Up to approximately 51 months from first randomization]
Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
- Change from Baseline in BPI-SF Worst Pain Score [Up to approximately 51 months from first randomization]
Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
- Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) [Up to approximately 51 months from first randomization]
EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine."
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Up to approximately 51 months from first randomization]
EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20) [Up to approximately 51 months from first randomization]
EORTC QLQ-MY20 includes scales for disease symptoms, side effects of treatment, future perspective, and body image. Values for each scale range from 0 to 100.
- Duration of response (DOR) [Up to approximately 43 months from first randomization]
DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
- Time to Disease Progression (TTP) [Up to approximately 43 months from first randomization]
TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
- Time to Response (TTR) [Up to approximately 43 months from first randomization]
TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).
- Cmax of Venetoclax [Up to approximately 225 days from initial dose]
Maximum plasma concentration (Cmax) of venetoclax
- Trough Concentration (Ctrough) of Venetoclax [Up to approximately 225 days from initial dose]
Observed plasma concentration at trough (Ctrough) of venetoclax.
- Number of Participants With Adverse Events (AEs) [Up to approximately 51 months from first randomization]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Documented diagnosis of multiple myeloma (MM) based on standard IMWG criteria.
-
Measurable disease at screening as defined per protocol.
-
Has received at least 2 prior lines of therapy as described in the protocol.
-
Has had documented disease progression on or within 60 days after completion of the last therapy.
-
Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
-
Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
-
Has MM positive for t(11;14).
-
An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
Exclusion Criteria:
-
History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
-
History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
-
Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
-
Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
-
Known central nervous system involvement of MM.
-
Concurrent conditions as listed in the protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Arizona Cancer Center - North Campus /ID# 218407 | Tucson | Arizona | United States | 85719-1478 |
2 | VA Central California Health Care System /ID# 200047 | Fresno | California | United States | 93703-2223 |
3 | University of California, Los Angeles /ID# 171524 | Los Angeles | California | United States | 90095 |
4 | Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904 | Aurora | Colorado | United States | 80045 |
5 | Mayo Clinic /ID# 200075 | Jacksonville | Florida | United States | 32224 |
6 | Cleveland Clinic Florida /ID# 208884 | Weston | Florida | United States | 33331-3609 |
7 | Norton Cancer Institute /ID# 200834 | Louisville | Kentucky | United States | 40202-3700 |
8 | Univ Maryland School Medicine /ID# 217422 | Baltimore | Maryland | United States | 21201-1544 |
9 | Boston Medical Center /ID# 223606 | Boston | Massachusetts | United States | 02118 |
10 | Barbara Ann Karmanos Cancer In /ID# 201377 | Detroit | Michigan | United States | 48201 |
11 | Henry Ford Hospital /ID# 171531 | Detroit | Michigan | United States | 48202 |
12 | Mayo Clinic - Rochester /ID# 201091 | Rochester | Minnesota | United States | 55905-0001 |
13 | Columbia University Medical Center /ID# 200715 | New York | New York | United States | 10032-3729 |
14 | Fairview Hospital - Moll Pavilion /ID# 208919 | Cleveland | Ohio | United States | 44111-5605 |
15 | Cleveland Clinic Main Campus /ID# 202247 | Cleveland | Ohio | United States | 44195 |
16 | UPMC Hillman Cancer Ctr /ID# 200063 | Pittsburgh | Pennsylvania | United States | 15232 |
17 | MD Anderson Cancer Center at Texas Medical Center /ID# 200060 | Houston | Texas | United States | 77030-4000 |
18 | Huntsman Cancer Institute /ID# 218406 | Salt Lake City | Utah | United States | 84112-5500 |
19 | VA Puget Sound Health Care System /ID# 222708 | Seattle | Washington | United States | 98108-1597 |
20 | Liverpool Hospital /ID# 202431 | Liverpool | New South Wales | Australia | 2170 |
21 | Sydney Adventist Hospital /ID# 222874 | Wahroonga | New South Wales | Australia | 2076 |
22 | Wollongong Hospital /ID# 205545 | Wollongong | New South Wales | Australia | 2500 |
23 | Icon Cancer Care - Townsville /ID# 206565 | Hyde Park | Queensland | Australia | 4812 |
24 | Icon Cancer Centre /ID# 205663 | South Brisbane | Queensland | Australia | 4101 |
25 | The Queen Elizabeth Hospital /ID# 202432 | Woodville South | South Australia | Australia | 5011 |
26 | Perth Blood Institute Ltd /ID# 206649 | Nedlands | Western Australia | Australia | 6009 |
27 | Tom Baker Cancer Centre /ID# 218846 | Calgary | Alberta | Canada | T2N 4N2 |
28 | BC Cancer - Vancouver /ID# 222804 | Vancouver | British Columbia | Canada | V5Z 1L3 |
29 | QE II Health Sciences Centre /ID# 218883 | Halifax | Nova Scotia | Canada | B3H 1V7 |
30 | CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887 | Levis | Quebec | Canada | G6V 3Z1 |
31 | Beijing Chaoyang Hospital,Capital Medical University /ID# 216014 | Beijing | Beijing | China | 100020 |
32 | Peking University Third Hospital /ID# 216371 | Beijing | Beijing | China | 100191 |
33 | Peking Union Medical College Hospital /ID# 216040 | Beijing | Beijing | China | 100730 |
34 | Sun Yat-Sen University Cancer Center /ID# 223828 | Guangzhou | Guangdong | China | 510060 |
35 | Guangdong Provincial People's Hospital /ID# 215860 | Guangzhou | Guangdong | China | 510080 |
36 | Henan Cancer Hospital /ID# 215987 | Zhengzhou | Henan | China | 450008 |
37 | Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850 | Wuhan | Hubei | China | 430022 |
38 | Nanjing Drum Tower Hospital /ID# 223143 | Nanjing | Jiangsu | China | 210008 |
39 | The First Affiliated Hospital of Soochow University /ID# 216094 | Suzhou | Jiangsu | China | 215006 |
40 | The First Affiliated Hospital of Nanchang University /ID# 216954 | Nanchang | Jiangxi | China | 330006 |
41 | The First Hospital of China Medical University /ID# 215996 | Shenyang | Liaoning | China | 110001 |
42 | Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643 | Shanghai | Shanghai | China | 200065 |
43 | Shanghai Tongji Hospital /ID# 218865 | Shanghai | Shanghai | China | 200065 |
44 | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041 | Tianjin | Tianjin | China | 300020 |
45 | Tianjin Medical University Cancer Institute & Hospital /ID# 223550 | Tianjin | Tianjin | China | 300060 |
46 | The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989 | Hangzhou | Zhejiang | China | 310006 |
47 | The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691 | Hangzhou | Zhejiang | China | 310006 |
48 | The First Affiliated Hospital of Wenzhou Medical University /ID# 218953 | Wenzhou | Zhejiang | China | 325000 |
49 | Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033 | Beijing | China | 100043 | |
50 | West China Hospital, Sichuan University /ID# 216647 | Chengdu | China | 610041 | |
51 | Shengjing Hospital of China Medical University /ID# 223435 | Shenyang | China | 110022 | |
52 | Fakultni Nemocnice Brno /ID# 204512 | Brno | Czechia | 625 00 | |
53 | Fakultni nemocnice Hradec Kralove /ID# 221291 | Hradec Kralove | Czechia | 500 05 | |
54 | Fakultni nemocnice Olomouc /ID# 221290 | Olomouc | Czechia | 779 00 | |
55 | Fakultni nemocnice Ostrava /ID# 204515 | Ostrava | Czechia | 708 52 | |
56 | Vseobecna fakultni nemocnice v Praze /ID# 221166 | Praha | Czechia | 128 08 | |
57 | Herlev Hospital /ID# 223221 | Herlev | Hovedstaden | Denmark | 2730 |
58 | Aalborg University Hospital /ID# 223220 | Aalborg | Nordjylland | Denmark | 9000 |
59 | Sygehus Lillebælt, Vejle /ID# 223216 | Vejle | Syddanmark | Denmark | 7100 |
60 | Odense Universitets Hospital /ID# 223217 | Odense C | Denmark | 5000 | |
61 | Roskilde Hospital /ID# 223366 | Roskilde | Denmark | 4000 | |
62 | HCL - Hôpital Lyon Sud /ID# 200097 | Pierre Benite CEDEX | Auvergne-Rhone-Alpes | France | 69495 |
63 | CHRU Lille - Hopital Claude Huriez /ID# 202213 | Lille | Hauts-de-France | France | 59037 |
64 | CHRU Nancy - Hôpitaux de Brabois /ID# 201076 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | France | 54500 |
65 | CHU de Nantes, Hotel Dieu -HME /ID# 200099 | Nantes | Pays-de-la-Loire | France | 44000 |
66 | CH Henri Duffaut /ID# 234154 | Avignon CEDEX 9 | Provence-Alpes-Cote-d Azur | France | 84902 |
67 | Hopital Henri Mondor /ID# 202211 | Creteil | France | 94000 | |
68 | CHU Grenoble - Hopital Michallon /ID# 223182 | La Tronche | France | 38700 | |
69 | Hopital Pitie Salpetriere /ID# 214173 | Paris | France | 75013 | |
70 | CHU Reims - Hôpital Robert Debre /ID# 233907 | Reims CEDEX | France | 51092 | |
71 | Centre Henri Becquerel /ID# 223186 | Rouen | France | 76038 | |
72 | Robert-Bosch-Krankenhaus /ID# 223947 | Stuttgart | Baden-Wuerttemberg | Germany | 70736 |
73 | Universitaetsklinikum Tuebingen /ID# 238646 | Tubingen | Baden-Wuerttemberg | Germany | 72076 |
74 | Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830 | Kiel | Schleswig-Holstein | Germany | 24105 |
75 | Universitaetsklinikum Jena /ID# 201254 | Jena | Thueringen | Germany | 07747 |
76 | Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051 | Berlin | Germany | 12203 | |
77 | Klinikum Chemnitz gGmbH /ID# 233797 | Chemnitz | Germany | 09116 | |
78 | Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 215495 | Hamburg | Germany | 20246 | |
79 | Asklepios Klinik Altona /ID# 222506 | Hamburg | Germany | 22763 | |
80 | Universitaetsklinikum Wuerzburg /ID# 200055 | Wuerzburg | Germany | 97080 | |
81 | Alexandra General Hospital /ID# 202386 | Athens | Attiki | Greece | 11528 |
82 | University General Hospital of Heraklion PA.G.N.I /ID# 222879 | Heraklion | Kriti | Greece | 71500 |
83 | General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982 | Athens | Greece | 10676 | |
84 | University Gen Hosp of Patra /ID# 201691 | Patras | Greece | 26504 | |
85 | Theageneio Anticancer Hospital /ID# 213983 | Thessaloniki | Greece | 54639 | |
86 | General Hospital of Thessaloniki George Papanikolaou /ID# 201692 | Thessaloniki | Greece | 57010 | |
87 | Soroka University Medical Center /ID# 218768 | Be'er Sheva | HaDarom | Israel | 8443901 |
88 | The Chaim Sheba Medical Center /ID# 169778 | Ramat Gan | Tel-Aviv | Israel | 5265601 |
89 | Tel Aviv Sourasky Medical Center /ID# 169437 | Tel Aviv-Yafo | Tel-Aviv | Israel | 6423906 |
90 | Assuta Ashdod Medical Center /ID# 222968 | Ashdod | Israel | 7747629 | |
91 | Rambam Health Care Campus /ID# 169678 | Haifa | Israel | 3109601 | |
92 | Bnai Zion Medical Center /ID# 169466 | Haifa | Israel | 3339419 | |
93 | The Lady Davis Carmel Medical Center /ID# 222969 | Haifa | Israel | 34362 | |
94 | Hadassah /ID# 169474 | Jerusalem | Israel | 91120 | |
95 | Rabin Medical Center /ID# 244611 | Petakh Tikva | Israel | 4941492 | |
96 | Irccs-Crob /Id# 170955 | Rionero in Vulture | Potenza | Italy | 85028 |
97 | Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950 | Ancona | Italy | 60126 | |
98 | IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952 | Bologna | Italy | 40138 | |
99 | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498 | Milan | Italy | 20122 | |
100 | A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988 | Palermo | Italy | 90146 | |
101 | Azienda Ospedaliera Santa Maria Terni /ID# 170948 | Terni | Italy | 05100 | |
102 | A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962 | Turin | Italy | 10126 | |
103 | Nagoya City University Hospital /ID# 170880 | Nagoya shi | Aichi | Japan | 467-8602 |
104 | The Jikei University Kashiwa Hospital /ID# 223031 | Kashiwa-shi | Chiba | Japan | 277-8567 |
105 | Kyushu University Hospital /ID# 171117 | Fukuoka-shi | Fukuoka | Japan | 812-8582 |
106 | Ogaki Municipal Hospital /ID# 171043 | Ogaki-shi | Gifu | Japan | 503-8502 |
107 | Gunma University Hospital /ID# 170966 | Maebashi-shi | Gunma | Japan | 371-8511 |
108 | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255 | Hiroshima-shi | Hiroshima | Japan | 730-8619 |
109 | Kobe City Medical Center General Hospital /ID# 170992 | Kobe-shi | Hyogo | Japan | 650-0047 |
110 | National Hospital Organization Mito Medical Center /ID# 171187 | Higashi Ibaraki-gun | Ibaraki | Japan | 311-3193 |
111 | Hitachi General Hospital /ID# 200843 | Hitachi-shi | Ibaraki | Japan | 317-0077 |
112 | Iwate Medical University Hospital /ID# 222849 | Shiwa-gun | Iwate | Japan | 028-3695 |
113 | Tohoku University Hospital /ID# 201935 | Sendai-shi | Miyagi | Japan | 9808574 |
114 | Okayama Medical Center /ID# 200119 | Okayama-shi | Okayama | Japan | 701-1192 |
115 | Japanese Red Cross Osaka Hospital /ID# 171493 | Osaka-shi | Osaka | Japan | 543-8555 |
116 | Osaka University Hospital /ID# 201966 | Suita-shi | Osaka | Japan | 565-0871 |
117 | Tokushima University Hospital /ID# 202571 | Tokushima-shi | Tokushima | Japan | 770-8503 |
118 | The Jikei University Hospital /ID# 239014 | Minato-ku | Tokyo | Japan | 105-8471 |
119 | Japanese Red Cross Medical Center /ID# 171256 | Shibuya-ku | Tokyo | Japan | 150-8935 |
120 | Yamagata University Hospital /ID# 238329 | Yamagata-shi | Yamagata | Japan | 990-9585 |
121 | Yonsei University Health System Severance Hospital /ID# 202709 | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 03722 |
122 | Gachon University Gil Medical Center /ID# 202827 | Incheon | Korea, Republic of | 21565 | |
123 | Seoul National University Hospital /ID# 202711 | Seoul | Korea, Republic of | 03080 | |
124 | Samsung Medical Center /ID# 202710 | Seoul | Korea, Republic of | 06351 | |
125 | The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045 | Seoul | Korea, Republic of | 06591 | |
126 | Ulsan University Hospital /ID# 222716 | Ulsan | Korea, Republic of | 44033 | |
127 | Moscow State budget healthcare /ID# 169685 | Moscow | Moskva | Russian Federation | 125284 |
128 | Research Institute of Fundamental and Clinical Immunology /ID# 223594 | Novosibirsk | Novosibirskaya Oblast | Russian Federation | 630099 |
129 | LLC Novaya Klinika /ID# 169689 | Pyatigorsk | Stavropol Skiy Kray | Russian Federation | 357500 |
130 | City Clinical Hospital #52 /ID# 206289 | Moscow | Russian Federation | 123182 | |
131 | Leningrad Regional Clinical Hospital /ID# 202776 | Saint Petersburg | Russian Federation | 194291 | |
132 | Almazov National Medical Research Centre /ID# 169681 | Sankt-Peterburg | Russian Federation | 197341 | |
133 | Tula Regional Clinical Hospital /ID# 223226 | Tula | Russian Federation | 300053 | |
134 | National University Hospital /ID# 203988 | Singapore | Singapore | 119228 | |
135 | Singapore General Hospital /ID# 202131 | Singapore | Singapore | 169608 | |
136 | Tan Tock Seng Hospital /ID# 204374 | Singapore | Singapore | 308433 | |
137 | Hospital Universitari Son Espases /ID# 222889 | Palma de Mallorca | Illes Balears | Spain | 07120 |
138 | Hospital Costa Del Sol /ID# 234083 | Marbella | Malaga | Spain | 29603 |
139 | Complejo Hospitalario Universitario Ourense /ID# 222876 | Orense | Ourense | Spain | 32005 |
140 | Hospital Universitario Canarias /ID# 238452 | San Cristóbal de La Laguna | Santa Cruz De Tenerife | Spain | 38320 |
141 | Hospital Universitario Vall d'Hebron /ID# 218106 | Barcelona | Spain | 08035 | |
142 | Instituto Catalan de Oncologia (ICO) Girona /ID# 171311 | Girona | Spain | 17007 | |
143 | Hospital de Leon /ID# 233878 | Leon | Spain | 24071 | |
144 | Hospital Universitario Fundacion Jimenez Diaz /ID# 171304 | Madrid | Spain | 28040 | |
145 | Hospital Universitario 12 de Octubre /ID# 171288 | Madrid | Spain | 28041 | |
146 | Hospital Universitario La Paz /ID# 218107 | Madrid | Spain | 28046 | |
147 | Hospital Universitario de Salamanca /ID# 171294 | Salamanca | Spain | 37711 | |
148 | Hospital Universitario Virgen del Rocio /ID# 171286 | Sevilla | Spain | 41013 | |
149 | Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887 | Toledo | Spain | 45007 | |
150 | Hospital Universitario y Politecnico La Fe /ID# 234019 | Valencia | Spain | 46026 | |
151 | Sunderby sjukhus /ID# 201314 | Lulea | Norrbottens Lan | Sweden | 971 80 |
152 | Sodra Alvsborgs sjukhus /ID# 213061 | Boras | Vastra Gotalands Lan | Sweden | 501 82 |
153 | Duplicate_Universitetssjukhuset Linköping /ID# 200789 | Linkoping | Vastra Gotalands Lan | Sweden | 581 85 |
154 | Uddevalla sjukhus /ID# 201315 | Uddevalla | Vastra Gotalands Lan | Sweden | 451 80 |
155 | Cukurova Universitesi Tip Fakultesi /ID# 201955 | Saricam Adana | Adana | Turkey | 01330 |
156 | Medical Park Izmir Hastanesi /ID# 201954 | Karsiyaka | Izmir | Turkey | 35575 |
157 | Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956 | Ankara | Turkey | 06200 | |
158 | Gazi University Medical Faculty /ID# 222698 | Ankara | Turkey | 06560 | |
159 | Ankara Univ Medical Faculty /ID# 201881 | Ankara | Turkey | 06590 | |
160 | Istanbul University Istanbul Medical Faculty /ID# 201953 | Istanbul | Turkey | 34093 | |
161 | Bagcilar Medipol Mega Universite Hastanesi /ID# 222914 | Istanbul | Turkey | 34214 | |
162 | Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952 | Istanbul | Turkey | 34899 | |
163 | Ege University Medical Faculty /ID# 222697 | Izmir | Turkey | 35040 | |
164 | Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943 | Cherkasy | Ukraine | 18009 | |
165 | Communal non-profit enterprise Regional Center of Oncology /ID# 223945 | Kharkiv | Ukraine | 61070 | |
166 | Khmelnytskyi Regional Hospital /ID# 223942 | Khmelnytskyi | Ukraine | 29000 | |
167 | National Cancer Institute /ID# 223944 | Kyiv | Ukraine | 03022 | |
168 | SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941 | Lviv | Ukraine | 79044 | |
169 | Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213 | Norwich | Norfolk | United Kingdom | NR4 7UY |
170 | Nottingham University Hospitals NHS Trust /ID# 223292 | Nottingham | Nottinghamshire | United Kingdom | NG5 1PB |
171 | NHS Greater Glasgow and Clyde /ID# 202199 | Glasgow | Scotland | United Kingdom | G12 0XH |
172 | University Hospitals of North Midlands NHS Trust /ID# 218355 | Stoke-on-Trent | Staffordshire | United Kingdom | ST4 6QG |
173 | Cambridge University Hospitals NHS Foundation Trust /ID# 223097 | Cambridge | United Kingdom | CB2 0QQ | |
174 | University College London Hospitals NHS Foundation Trust /ID# 171428 | London | United Kingdom | NW1 2PG | |
175 | Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445 | London | United Kingdom | SE13 6LH | |
176 | Imperial College Healthcare NHS Trust /ID# 171446 | London | United Kingdom | W2 1NY | |
177 | Manchester University NHS Foundation Trust /ID# 171440 | Manchester | United Kingdom | M13 9WL | |
178 | Portsmouth Hospitals University NHS Trust /ID# 171444 | Portsmouth | United Kingdom | PO6 3LY | |
179 | Royal Berkshire NHS Foundation Trust /ID# 217835 | Reading | United Kingdom | RG1 5AN | |
180 | Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447 | Sheffield | United Kingdom | S5 7AT |
Sponsors and Collaborators
- AbbVie
- Roche-Genentech
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M13-494
- 2017-003838-88