A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03539744
Collaborator
Roche-Genentech (Industry)
254
180
2
72.7
1.4
0

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

Study Type:
Interventional
Actual Enrollment :
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
Actual Study Start Date :
Oct 22, 2018
Actual Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Nov 11, 2024

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:
  • ABT-199
  • GDC-0199
  • 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:
  • Pomalyst
  • Drug: Dexamethasone
    oral, locally available form

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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).

    5. 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).

    6. 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).

    7. 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.

    8. 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.

    9. 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."

    10. 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).

    11. 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.

    12. 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.

    13. 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.

    14. 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).

    15. Cmax of Venetoclax [Up to approximately 225 days from initial dose]

      Maximum plasma concentration (Cmax) of venetoclax

    16. Trough Concentration (Ctrough) of Venetoclax [Up to approximately 225 days from initial dose]

      Observed plasma concentration at trough (Ctrough) of venetoclax.

    17. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03539744
    Other Study ID Numbers:
    • M13-494
    • 2017-003838-88
    First Posted:
    May 29, 2018
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022