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Активно (без набиране) Фаза 3 NCT03539744

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.

Фаза 3 – широко изпитване преди одобрение
Заболявания: Multiple Myeloma

Спонсор: AbbVie

Налично на: БГ
Обобщение
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
Кой може да участва
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (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 t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing. * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * 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.
Места на провеждане 19
Австралия (1)
Liverpool Hospital /ID# 202431
Liverpool , New South Wales
Канада (1)
Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846
Calgary , Alberta
Китай (1)
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
Beijing , Beijing Municipality
Чехия (1)
Fakultní Nemocnice Brno - Jihlavská /ID# 204512
Brno , Brno-mesto
Дания (1)
Duplicate_Herlev Hospital /ID# 223221
Herlev , Capital Region
Франция (1)
Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182
La Tronche , Isere
Гърция (1)
Alexandra General Hospital /ID# 202386
Athens , Attica
Израел (1)
Rambam Health Care Campus /ID# 169678
Haifa , H_efa
Италия (1)
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 170952
Bologna , Emilia-Romagna
Япония (1)
Nagoya City University Hospital /ID# 170880
Nagoya , Aichi-ken
Russia (1)
Moscow State budget healthcare /ID# 169685
Moscow , Moscow
Сингапур (1)
National University Hospital /ID# 203988
Singapore
Южна Корея (1)
Duplicate_Gachon University Gil Medical Center /ID# 202827
Incheon , Gyeonggido
Испания (1)
Hospital Universitari Son Espases /ID# 222889
Palma de Mallorca , Balearic Islands
Швеция (1)
Sunderby sjukhus /ID# 201314
Luleå , Norrbotten County
Турция (1)
Cukurova Universitesi Tip Fakultesi /ID# 201955
Saricam Adana , Adana
Ukraine (1)
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
Cherkasy , Cherkasy Oblast
Великобритания (1)
Addenbrooke's Hospital /ID# 223097
Cambridge , Cambridgeshire
САЩ (1)
Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407
Tucson , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.10.2018
Крайна дата
01.11.2027
Регистрационен номер
NCT03539744
Източник
anzctr
Запитване за медицински туризъм

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