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.

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03539744
• Other study ID #: M13-494
• Secondary ID: 2017-003838-8820
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 22, 2018
• Est. completion date: February 25, 2026

Study information

• Verified date: February 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 265
• Est. completion date: February 25, 2026
• Est. primary completion date: February 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Pomalidomide
capsule, oral
• Dexamethasone
oral, locally available form
• Venetoclax
tablet; oral

Locations

Country	Name	City	State
Australia	ICON Cancer Care - Townsville /ID# 206565	Hyde Park	Queensland
Australia	Liverpool Hospital /ID# 202431	Liverpool	New South Wales
Australia	Perth Blood Institute Ltd /ID# 206649	Nedlands	Western Australia
Australia	Icon Cancer Centre /ID# 205663	South Brisbane	Queensland
Australia	Sydney Adventist Hospital /ID# 222874	Wahroonga	New South Wales
Australia	Wollongong Hospital /ID# 205545	Wollongong	New South Wales
Australia	The Queen Elizabeth Hospital /ID# 202432	Woodville South	South Australia
Canada	Tom Baker Cancer Centre /ID# 218846	Calgary	Alberta
Canada	QE II Health Sciences Centre /ID# 218883	Halifax	Nova Scotia
Canada	CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887	Levis	Quebec
Canada	BC Cancer - Vancouver /ID# 222804	Vancouver	British Columbia
China	Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033	Beijing
China	Beijing Chaoyang Hospital,Capital Medical University /ID# 216014	Beijing	Beijing
China	Peking Union Medical College Hospital /ID# 216040	Beijing	Beijing
China	Peking University Third Hospital /ID# 216371	Beijing	Beijing
China	West China Hospital, Sichuan University /ID# 216647	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital /ID# 215860	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center /ID# 223828	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 216954	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 223143	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643	Shanghai	Shanghai
China	Shanghai Tongji Hospital /ID# 218865	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 223435	Shenyang	Liaoning
China	The First Hospital of China Medical University /ID# 215996	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University /ID# 216094	Suzhou	Jiangsu
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital /ID# 223550	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University /ID# 218953	Wenzhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850	Wuhan	Hubei
China	Henan Cancer Hospital /ID# 215987	Zhengzhou	Henan
Czechia	Fakultni Nemocnice Brno /ID# 204512	Brno
Czechia	Fakultni nemocnice Hradec Kralove /ID# 221291	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc /ID# 221290	Olomouc
Czechia	Fakultni Nemocnice Ostrava /ID# 204515	Ostrava
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 221166	Praha
Denmark	Aalborg University Hospital /ID# 223220	Aalborg	Nordjylland
Denmark	Herlev Hospital /ID# 223221	Herlev	Hovedstaden
Denmark	Odense Universitets Hospital /ID# 223217	Odense C	Syddanmark
Denmark	Roskilde Hospital /ID# 223366	Roskilde
Denmark	Sygehus Lillebalt, Vejle /ID# 223216	Vejle	Syddanmark
France	CH Henri Duffaut /ID# 234154	Avignon CEDEX 9	Vaucluse
France	Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 202211	Créteil
France	CHU Grenoble - Hopital Michallon /ID# 223182	La Tronche
France	CHRU Lille - Hopital Claude Huriez /ID# 202213	Lille	Nord
France	CHU de Nantes, Hotel Dieu -HME /ID# 200099	Nantes	Pays-de-la-Loire
France	Hopital Pitie Salpetriere /ID# 214173	Paris
France	HCL - Hopital Lyon Sud /ID# 200097	Pierre Benite CEDEX	Rhone
France	CHU Reims - Hôpital Robert Debre /ID# 233907	Reims CEDEX	Marne
France	Centre Henri Becquerel /ID# 223186	Rouen
France	CHRU Nancy - Hopitaux de Brabois /ID# 201076	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051	Berlin
Germany	Klinikum Chemnitz gGmbH /ID# 233797	Chemnitz
Germany	Asklepios Klinik Altona /ID# 222506	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 215495	Hamburg
Germany	Universitaetsklinikum Jena /ID# 201254	Jena	Thueringen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830	Kiel	Schleswig-Holstein
Germany	Robert-Bosch-Krankenhaus /ID# 223947	Stuttgart	Baden-Wuerttemberg
Germany	Universitaetsklinikum Tuebingen /ID# 238646	Tubingen	Baden-Wuerttemberg
Germany	Universitaetsklinikum Wuerzburg /ID# 200055	Wuerzburg
Greece	Alexandra General Hospital /ID# 202386	Athens	Attiki
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982	Athens
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 222879	Heraklion	Kriti
Greece	University Gen Hosp of Patra /ID# 201691	Patras
Greece	General Hospital of Thessaloniki George Papanikolaou /ID# 201692	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 213983	Thessaloniki
Israel	Assuta Ashdod Medical Center /ID# 222968	Ashdod	HaDarom
Israel	Soroka University Medical Center /ID# 218768	Be'er Sheva	HaDarom
Israel	Bnai Zion Medical Center /ID# 169466	Haifa	H_efa
Israel	Rabin Medical Center /ID# 244611	Haifa	H_efa
Israel	Rambam Health Care Campus /ID# 169678	Haifa	H_efa
Israel	The Lady Davis Carmel Medical Center /ID# 222969	Haifa	H_efa
Israel	Hadassah /ID# 169474	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 169778	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 169437	Tel Aviv	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950	Ancona
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952	Bologna
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498	Milan
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988	Palermo
Italy	Irccs-Crob /Id# 170955	Rionero in Vulture	Potenza
Italy	Azienda Ospedaliera Santa Maria Terni /ID# 170948	Terni
Italy	A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962	Turin	Torino
Japan	Kyushu University Hospital /ID# 171117	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Mito Medical Center /ID# 171187	Higashi Ibaraki-gun	Ibaraki
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255	Hiroshima-shi	Hiroshima
Japan	Hitachi General Hospital /ID# 200843	Hitachi-shi	Ibaraki
Japan	The Jikei University Kashiwa Hospital /ID# 223031	Kashiwa-shi	Chiba
Japan	Kobe City Medical Center General Hospital /ID# 170992	Kobe-shi	Hyogo
Japan	Gunma University Hospital /ID# 170966	Maebashi-shi	Gunma
Japan	The Jikei University Hospital /ID# 239014	Minato-ku	Tokyo
Japan	Nagoya City University Hospital /ID# 170880	Nagoya shi	Aichi
Japan	Ogaki Municipal Hospital /ID# 171043	Ogaki-shi	Gifu
Japan	Okayama Medical Center /ID# 200119	Okayama-shi	Okayama
Japan	Japanese Red Cross Osaka Hospital /ID# 171493	Osaka-shi	Osaka
Japan	Tohoku University Hospital /ID# 201935	Sendai-shi	Miyagi
Japan	Japanese Red Cross Medical Center /ID# 171256	Shibuya-ku	Tokyo
Japan	Iwate Medical University Hospital /ID# 222849	Shiwa-gun	Iwate
Japan	Osaka University Hospital /ID# 201966	Suita-shi	Osaka
Japan	Tokushima University Hospital /ID# 202571	Tokushima-shi	Tokushima
Japan	Yamagata University Hospital /ID# 238329	Yamagata-shi	Yamagata
Korea, Republic of	Gachon University Gil Medical Center /ID# 202827	Incheon
Korea, Republic of	Samsung Medical Center /ID# 202710	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 202711	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 202709	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Ulsan University Hospital /ID# 222716	Ulsan
Russian Federation	City Clinical Hospital #52 /ID# 206289	Moscow
Russian Federation	Moscow State budget healthcare /ID# 169685	Moscow	Moskva
Russian Federation	Research Institute of Fundamental and Clinical Immunology /ID# 223594	Novosibirsk	Novosibirskaya Oblast
Russian Federation	LLC Novaya Klinika /ID# 169689	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Leningrad Regional Clinical Hospital /ID# 202776	Saint Petersburg
Russian Federation	Almazov National Medical Research Centre /ID# 169681	Sankt-Peterburg
Russian Federation	Tula Regional Clinical Hospital /ID# 223226	Tula
Singapore	National University Hospital /ID# 203988	Singapore
Singapore	Singapore General Hospital /ID# 202131	Singapore
Singapore	Tan Tock Seng Hospital /ID# 204374	Singapore
Spain	Hospital Universitario Vall d'Hebron /ID# 218106	Barcelona
Spain	Instituto Catalan de Oncologia (ICO) Girona /ID# 171311	Girona
Spain	Hospital de Leon /ID# 233878	Leon
Spain	Hospital Universitario 12 de Octubre /ID# 171288	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 171304	Madrid
Spain	Hospital Universitario La Paz /ID# 218107	Madrid
Spain	Hospital Costa del Sol /ID# 234083	Marbella	Malaga
Spain	Complejo Hospitalario Universitario Ourense /ID# 222876	Orense	Ourense
Spain	Hospital Universitari Son Espases /ID# 222889	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario de Salamanca /ID# 171294	Salamanca
Spain	Hospital Universitario Canarias /ID# 238452	San Cristóbal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Virgen del Rocio /ID# 171286	Sevilla
Spain	Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887	Toledo
Spain	Hospital Universitario y Politecnico La Fe /ID# 234019	Valencia
Sweden	Sodra Alvsborgs sjukhus /ID# 213061	Boras	Vastra Gotalands Lan
Sweden	Duplicate_Universitetssjukhuset Linköping /ID# 200789	Linkoping	Vastra Gotalands Lan
Sweden	Sunderby sjukhus /ID# 201314	Lulea	Norrbottens Lan
Sweden	Uddevalla sjukhus /ID# 201315	Uddevalla	Vastra Gotalands Lan
Turkey	Ankara Univ Medical Faculty /ID# 201881	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956	Ankara
Turkey	Gazi University Medical Faculty /ID# 222698	Ankara
Turkey	Bagcilar Medipol Mega Universite Hastanesi /ID# 222914	Istanbul
Turkey	Istanbul University Istanbul Medical Faculty /ID# 201953	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952	Istanbul
Turkey	Ege University Medical Faculty /ID# 222697	Izmir
Turkey	Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954	Karsiyaka	Izmir
Turkey	Cukurova Universitesi Tip Fakultesi /ID# 201955	Saricam Adana	Adana
Ukraine	Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943	Cherkasy
Ukraine	Communal non-profit enterprise Regional Center of Oncology /ID# 223945	Kharkiv
Ukraine	MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942	Khmelnytskyi
Ukraine	National Cancer Institute /ID# 223944	Kyiv
Ukraine	SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941	Lviv
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 223097	Cambridge
United Kingdom	NHS Greater Glasgow and Clyde /ID# 202199	Glasgow	Scotland
United Kingdom	Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445	London
United Kingdom	Imperial College Healthcare NHS Trust /ID# 171446	London
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 171428	London
United Kingdom	Manchester University NHS Foundation Trust /ID# 171440	Manchester
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213	Norwich	Norfolk
United Kingdom	Nottingham University Hospitals NHS Trust /ID# 223292	Nottingham	Nottinghamshire
United Kingdom	Portsmouth Hospitals University NHS Trust /ID# 171444	Portsmouth
United Kingdom	Royal Berkshire NHS Foundation Trust /ID# 217835	Reading
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447	Sheffield
United Kingdom	University Hospitals of North Midlands NHS Trust /ID# 218355	Stoke-on-Trent	Staffordshire
United States	Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904	Aurora	Colorado
United States	University of Maryland School of Medicine /ID# 217422	Baltimore	Maryland
United States	Boston Medical Center /ID# 223606	Boston	Massachusetts
United States	Cleveland Clinic Main Campus /ID# 202247	Cleveland	Ohio
United States	Fairview Hospital - Moll Pavilion /ID# 208919	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer In /ID# 201377	Detroit	Michigan
United States	Henry Ford Hospital /ID# 171531	Detroit	Michigan
United States	VA Central California Health Care System /ID# 200047	Fresno	California
United States	MD Anderson Cancer Center at Texas Medical Center /ID# 200060	Houston	Texas
United States	Mayo Clinic /ID# 200075	Jacksonville	Florida
United States	University of California, Los Angeles /ID# 171524	Los Angeles	California
United States	Duplicate_Norton Cancer Institute /ID# 200834	Louisville	Kentucky
United States	Columbia University Medical Center /ID# 200715	New York	New York
United States	UPMC Hillman Cancer Ctr /ID# 200063	Pittsburgh	Pennsylvania
United States	Mayo Clinic - Rochester /ID# 201091	Rochester	Minnesota
United States	Huntsman Cancer Institute /ID# 218406	Salt Lake City	Utah
United States	VA Puget Sound Health Care System /ID# 222708	Seattle	Washington
United States	University of Arizona Cancer Center - North Campus /ID# 218407	Tucson	Arizona
United States	Cleveland Clinic Florida /ID# 208884	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Roche-Genentech

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Singapore,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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.	Up to approximately 43 months from first randomization
Secondary	Overall Response Rate (ORR)	ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.	Up to approximately 43 months from first randomization
Secondary	Very Good Partial Response or Better Response Rate (VGPR)	VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.	Up to approximately 43 months from first randomization
Secondary	Overall survival (OS)	OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.	Up to approximately 51 months from first randomization
Secondary	Minimal Residual Disease (MRD) Negativity Rate	MRD defined as the percentage 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).	Up to approximately 43 months from first randomization
Secondary	Time to Deterioration in Disease Symptoms	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).	Up to approximately 51 months from first randomization
Secondary	Time to Deterioration in Physical Functioning	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).	Up to approximately 51 months from first randomization
Secondary	Change from Baseline in PROMIS Fatigue Score	Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.	Up to approximately 51 months from first randomization
Secondary	Change from Baseline in BPI-SF Worst Pain Score	Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.	Up to approximately 51 months from first randomization
Secondary	Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)	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."	Up to approximately 51 months from first randomization
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	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).	Up to approximately 51 months from first randomization
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)	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.	Up to approximately 51 months from first randomization
Secondary	Duration of response (DOR)	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.	Up to approximately 43 months from first randomization
Secondary	Time to Disease Progression (TTP)	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.	Up to approximately 43 months from first randomization
Secondary	Time to Response (TTR)	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).	Up to approximately 43 months from first randomization
Secondary	Cmax of Venetoclax	Maximum plasma concentration (Cmax) of venetoclax	Up to approximately 225 days from initial dose
Secondary	Trough Concentration (Ctrough) of Venetoclax	Observed plasma concentration at trough (Ctrough) of venetoclax.	Up to approximately 225 days from initial dose
Secondary	Number of Participants With Adverse Events (AEs)	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.	Up to approximately 51 months from first randomization

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