Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

October 10, 2012

Primary Completion Date

November 29, 2021

Study Completion Date

November 29, 2021

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

Venetoclax

Each dose of venetoclax was to be taken with approximately 240 mL of water. On days that pre-dose pharmacokinetic (PK) sampling was required, dosing was to occur in the morning at the clinic at approximately 0900 (± 1 hour) to facilitate PK sampling. Dose Escalation cohort participants were to take venetoclax within 30 minutes after the completion of a standard low-fat breakfast with approximately 240 mL of water on Cycle 2 Day 1. On all other dosing days, participants were instructed to take venetoclax orally QD within 30 minutes after the completion of a low-fat breakfast. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed.

DRUG

Dexamethasone

Tablets were administered by mouth per the dexamethasone prescribing information.

Trial Locations (29)

1090

UZ Brussel /ID# 170711, Jette

2060

ZNA Stuivenberg /ID# 170067, Antwerp

3000

Duplicate_University Hospital Leuven /ID# 170715, Leuven

30322

Emory University, Winship Cancer Institute /ID# 74993, Atlanta

37044

CHRU Tours - Hopital Bretonneau /ID# 126639, Tours

38043

Duplicate_CHU Grenoble - Hopital Michallon /ID# 126658, Grenoble

39401

Hattiesburg Clinic /ID# 201187, Hattiesburg

43210

Ohio State Cancer Center /ID# 200249, Columbus

44000

CHU de Nantes, Hotel Dieu -HME /ID# 75033, Nantes

48109

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007, Ann Arbor

57105

Avera Cancer Institute /ID# 204178, Sioux Falls

59037

CHRU Lille - Hopital Claude Huriez /ID# 74995, Lille

60426

Ingalls Memorial Hosp /ID# 205346, Harvey

63110

Washington University-School of Medicine /ID# 76094, St Louis

70112

Tulane Cancer Center Clinic /ID# 204123, New Orleans

72205

University of Arkansas for Medical Sciences /ID# 170002, Little Rock

75246

Baylor University Medical Ctr. /ID# 170056, Dallas

98104

Swedish Cancer Institute - Edmonds /ID# 170006, Seattle

85259-5452

Mayo Clinic - Scottsdale /ID# 75808, Scottsdale

06510

Yale University /ID# 203704, New Haven

02111-1552

Tufts Medical Center /ID# 203814, Boston

55905-0001

Mayo Clinic - Rochester /ID# 74994, Rochester

68198-6840

University of Nebraska Medical Center /ID# 169158, Omaha

07601

The John Theurer Cancer /ID# 200248, Hackensack

27710-3000

Duke Cancer Center /ID# 129356, Durham

44106-1716

University Hospitals - Seidman Cancer Center /ID# 204502, Cleveland

53792-0001

Univ of Wisconsin Hosp/Clinics /ID# 200246, Madison

53226-3522

Medical College of Wisconsin /ID# 205229, Milwaukee

0450

Ulleval, OUS /ID# 170707, Oslo

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY