Back to resultsStudy of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carfilzomib
Venetoclax
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Refractory myeloma, Relapsed myeloma, Relapsed or Refractory
Eligibility Criteria
Inclusion Criteria:
- Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2.
- Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
- Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
- Received prior treatment with at least 1 prior line of therapy for MM.
- Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
- Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.
Exclusion Criteria:
Has a pre-existing condition that is contraindicated including.
- Non-secretory or oligo-secretory MM
- Active plasma cell leukemia.
- Waldenström's macroglobulinemia.
- Primary amyloidosis.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Active hepatitis B or C infection based on screening blood testing.
- Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Significant cardiovascular disease.
- Major surgery within 4 weeks prior to first dose.
- Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose.
- Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
- Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose.
- Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study.
- History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- University of Alabama at Birmingham - Main /ID# 151405Recruiting
- University of Arkansas for Medical Sciences /ID# 151399
- Memorial Healthcare System /ID# 224862
- Emory University, Winship Cancer Institute /ID# 161710Recruiting
- The University of Chicago Medical Center /ID# 151395Recruiting
- Indiana Blood & Marrow Transpl /ID# 218862Recruiting
- University of Kentucky Chandler Medical Center /ID# 151407
- Central Maine Medical Center /ID# 218856
- University of Maryland School of Medicine /ID# 159721
- Washington University-School of Medicine /ID# 222651Recruiting
- Oncology Hematology Associates (OHA) - Springfield /ID# 218855Recruiting
- Duke Cancer Center /ID# 162062Recruiting
- University of Pennsylvania /ID# 151768Recruiting
- University of Texas Southwestern Medical Center /ID# 218336Recruiting
- Baylor Scott & White Medical Center- Temple /ID# 218252
- University of Utah /ID# 151397Recruiting
- Duplicate_VA Puget Sound Healthcare Syst /ID# 155369
- Aurora Health Care, Aurora Cancer Center /ID# 209612Recruiting
- Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 222200Recruiting
- Calvary Mater Newcastle /ID# 218739Recruiting
- Flinders Medical Centre /ID# 221345Recruiting
- Royal Hobart Hospital /ID# 217546Recruiting
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 219172Recruiting
- Debreceni Egyetem Klinikai Kozpont /ID# 217624Recruiting
- Semmelweis Egyetem /ID# 217626Recruiting
- Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625Recruiting
- Auxilio Mutuo Cancer Center /ID# 157853Recruiting
- VA Caribbean Healthcare System /ID# 157854
- Hospital Universitario Germans Trias i Pujol /ID# 218006Recruiting
- Hospital Clinic de Barcelona /ID# 218007Recruiting
- Hospital General Universitario Gregorio Maranon /ID# 218005Recruiting
- Hospital Universitario Ramon y Cajal /ID# 220925Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venetoclax + Carfilzomib + Dexamethasone
Arm Description
Part 1: Evaluate the safety and pharmacokinetic profiles while providing information to determine the appropriate doses of venetoclax and carfilzomib (VenKd) to be used in the VenKd combination in approximately 18 participants. The dose levels are Venetoclax 400 mg or 800 mg; Carfilzomib 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; Dexamethasone 40 mg Part 2: Further evaluate the safety and efficacy profile of the VenKd combination selected after completion of Part 1 in approximately 22 additional participants. Participants may discontinue Kd but may continue receiving venetoclax once daily (QD) as monotherapy. Part 3: Further evaluation of the efficacy of the VenKd combination after completion of Part 1 and Part 2 in 7 additional participants. Part 4, An additional 65 participants t(11;14) positive will receive varying doses of the VenKd combination or carfilzomib and dexamethasone
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Very Good Partial Response (VGPR) or Better Response Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
VGPR or better response rate is defined as the percentage of participants with documented VGPR or better based on IMWG criteria.
Objective Response Rate (ORR) of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
ORR is defined as the percentage of participants with a documented PR or better based on IMWG criteria.
Complete Response (CR) or Better Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Complete response or better rate is defined as the percentage of participants with documented CR or better based on IMWG criteria.
Secondary Outcome Measures
Very Good Partial Response (VGPR) or Better Response Rate in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
VGPR or better response rate is defined as the proportion of participants with documented VGPR or better based on IMWG criteria.
Progression-free survival (PFS) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
PFS is defined as the number of days from the date of the first dose of study drug to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Minimal residual disease (MRD)
MRD in the bone marrow by next generation sequencing.
Duration of Overall Response (DOR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
DOR is defined as the number of days from the participant's date of first documented response (PR or better) to the date of first documented PD or death due to MM, whichever occurs first.
Time to progression (TTP) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
TTP is defined as the number of days from the date of the first dose of study drug to the date of first documented PD or death due to MM, whichever occurs first.
Objective response rate (ORR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
ORR is defined as the proportion of participants with documented partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria.
Time to Response (TTR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
TTR is defined as the number of days from the date of the first dose of study drug to the date of first documented response (Partial Response (PR) or better).
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
AUC0-24 post-dose of venetoclax.
Clearance (CL) of Carfilzomib
CL of carfilzomib.
Terminal Phase Elimination Rate Constant (β) of Carfilzomib
β of carfilzomib.
AUC from 0 to Infinity (AUC∞) of Carfilzomib
AUC∞ of carfilzomib.
AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib
AUCt of carfilzomib.
Maximum Plasma Concentration (Cmax) of Venetoclax
Cmax of venetoclax.
Cmax of Carfilzomib
Cmax of carfilzomib.
Terminal Elimination Half-life (t1/2) of Carfilzomib
t1/2 of carfilzomib.
Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax
(Peak time, Tmax) of venetoclax.
Full Information
NCT ID
NCT02899052
First Posted
September 1, 2016
Last Updated
July 24, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc; Onyx Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02899052
Brief Title
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Official Title
A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
March 25, 2027 (Anticipated)
Study Completion Date
March 25, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc; Onyx Therapeutics, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy.
Part 4 of this study is currently enrolling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Refractory myeloma, Relapsed myeloma, Relapsed or Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venetoclax + Carfilzomib + Dexamethasone
Arm Type
Experimental
Arm Description
Part 1: Evaluate the safety and pharmacokinetic profiles while providing information to determine the appropriate doses of venetoclax and carfilzomib (VenKd) to be used in the VenKd combination in approximately 18 participants. The dose levels are Venetoclax 400 mg or 800 mg; Carfilzomib 20/27 mg/m2, 20/70 mg/m2, and/or 20/56 mg/m2; Dexamethasone 40 mg
Part 2: Further evaluate the safety and efficacy profile of the VenKd combination selected after completion of Part 1 in approximately 22 additional participants. Participants may discontinue Kd but may continue receiving venetoclax once daily (QD) as monotherapy.
Part 3: Further evaluation of the efficacy of the VenKd combination after completion of Part 1 and Part 2 in 7 additional participants.
Part 4, An additional 65 participants t(11;14) positive will receive varying doses of the VenKd combination or carfilzomib and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Kyprolis
Intervention Description
Carfilzomib lyophilized administered intravenously as a 10 to 30 minute infusion in Cycles 1 and beyond within 30 minutes to 4 hours after dexamethasone dosing.
Dose level 1 (K1) Cycle 1: 20 mg/m2 on Days 1 and 2, 27 mg/m2 on Days 8, 9, 15, and 16; Cycles 2 - 12: 27 mg/m2 on Days 1, 2, 8, 9, 15, and 16; Cycles 13 - 18: 27 mg/m2 on Days 1, 2, 15, and 16; Cycles 19 and beyond, for participants that have not previously transitioned to monotherapy: 27 mg/m2 on Days 1, 2, 15, and 16.
Dose Level K2: Cycle 1: 20 mg/m2 on Day 1; 70 mg/m2 on Days 8 and 15 Cycles 2 - onward: 70 mg/m2 on Days 1, 8, and 15. Dose Level K3: Cycle 1: 20 mg/m2 on Days 1 and 2; 56 mg/m2 on Days 8, 9, 15, and 16.
Cycles 2 - onward: 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta, ABT-199
Intervention Description
Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone tablet administered orally during Cycles 1 - onward. Dexamethasone dose level 1 (Dex1) 40 mg once weekly, Dex2 40 mg once weekly, Dex3 20 mg twice weekly.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Title
Very Good Partial Response (VGPR) or Better Response Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Description
VGPR or better response rate is defined as the percentage of participants with documented VGPR or better based on IMWG criteria.
Time Frame
First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Title
Objective Response Rate (ORR) of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Description
ORR is defined as the percentage of participants with a documented PR or better based on IMWG criteria.
Time Frame
First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Title
Complete Response (CR) or Better Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM
Description
Complete response or better rate is defined as the percentage of participants with documented CR or better based on IMWG criteria.
Time Frame
First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Secondary Outcome Measure Information:
Title
Very Good Partial Response (VGPR) or Better Response Rate in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
VGPR or better response rate is defined as the proportion of participants with documented VGPR or better based on IMWG criteria.
Time Frame
Up to approximately 17 months
Title
Progression-free survival (PFS) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
PFS is defined as the number of days from the date of the first dose of study drug to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 17 months
Title
Minimal residual disease (MRD)
Description
MRD in the bone marrow by next generation sequencing.
Time Frame
Up to 2 years (Screening, Cycle 3 Day 1, and Confirmation of Stringent Complete Response [sCR]/Complete Response [CR])
Title
Duration of Overall Response (DOR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
DOR is defined as the number of days from the participant's date of first documented response (PR or better) to the date of first documented PD or death due to MM, whichever occurs first.
Time Frame
Up to approximately 17 months
Title
Time to progression (TTP) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
TTP is defined as the number of days from the date of the first dose of study drug to the date of first documented PD or death due to MM, whichever occurs first.
Time Frame
Up to approximately 17 months
Title
Objective response rate (ORR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
ORR is defined as the proportion of participants with documented partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria.
Time Frame
Up to approximately 17 months
Title
Time to Response (TTR) in Participants with Relapsed or Refractory Multiple Myeloma and in a Subset of Participants with High B-cell lymphocyte-2 (BCL-2) Expression
Description
TTR is defined as the number of days from the date of the first dose of study drug to the date of first documented response (Partial Response (PR) or better).
Time Frame
Up to approximately 17 months
Title
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
Description
AUC0-24 post-dose of venetoclax.
Time Frame
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Title
Clearance (CL) of Carfilzomib
Description
CL of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
Terminal Phase Elimination Rate Constant (β) of Carfilzomib
Description
β of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
AUC from 0 to Infinity (AUC∞) of Carfilzomib
Description
AUC∞ of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib
Description
AUCt of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
Maximum Plasma Concentration (Cmax) of Venetoclax
Description
Cmax of venetoclax.
Time Frame
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Title
Cmax of Carfilzomib
Description
Cmax of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
Terminal Elimination Half-life (t1/2) of Carfilzomib
Description
t1/2 of carfilzomib.
Time Frame
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Title
Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax
Description
(Peak time, Tmax) of venetoclax.
Time Frame
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2.
Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
Received prior treatment with at least 1 prior line of therapy for MM.
Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.
Exclusion Criteria:
Has a pre-existing condition that is contraindicated including.
Non-secretory or oligo-secretory MM
Active plasma cell leukemia.
Waldenström's macroglobulinemia.
Primary amyloidosis.
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Active hepatitis B or C infection based on screening blood testing.
Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Significant cardiovascular disease.
Major surgery within 4 weeks prior to first dose.
Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose.
Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose.
Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study.
History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 151405
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arkansas for Medical Sciences /ID# 151399
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Healthcare System /ID# 224862
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-3513
Country
United States
Individual Site Status
Completed
Facility Name
Emory University, Winship Cancer Institute /ID# 161710
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Chicago Medical Center /ID# 151395
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana Blood & Marrow Transpl /ID# 218862
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Chandler Medical Center /ID# 151407
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Completed
Facility Name
Central Maine Medical Center /ID# 218856
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland School of Medicine /ID# 159721
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Completed
Facility Name
Washington University-School of Medicine /ID# 222651
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology Associates (OHA) - Springfield /ID# 218855
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-5287
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Cancer Center /ID# 162062
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania /ID# 151768
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center /ID# 218336
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 218252
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Individual Site Status
Completed
Facility Name
University of Utah /ID# 151397
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Individual Site Status
Recruiting
Facility Name
Duplicate_VA Puget Sound Healthcare Syst /ID# 155369
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Completed
Facility Name
Aurora Health Care, Aurora Cancer Center /ID# 209612
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226-3436
Country
United States
Individual Site Status
Recruiting
Facility Name
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 222200
City
East Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle /ID# 218739
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre /ID# 221345
City
Bedford, Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital /ID# 217546
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 219172
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 217624
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem /ID# 217626
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Auxilio Mutuo Cancer Center /ID# 157853
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
VA Caribbean Healthcare System /ID# 157854
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Individual Site Status
Completed
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 218006
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona /ID# 218007
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 218005
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal /ID# 220925
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
34470049
Citation
Costa LJ, Davies FE, Monohan GP, Kovacsovics T, Burwick N, Jakubowiak A, Kaufman JL, Hong WJ, Dail M, Salem AH, Yang X, Masud AA, Munasinghe W, Ross JA, Bueno OF, Kumar SK, Stadtmauer EA. Phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Blood Adv. 2021 Oct 12;5(19):3748-3759. doi: 10.1182/bloodadvances.2020004146.
Results Reference
derived
Learn more about this trial
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
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