A Phase 2 interventional study of Carfilzomib and Venetoclax in Multiple Myeloma, sponsored by AbbVie. Active, not recruiting at 32 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 120 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has a pre-existing condition that is contraindicated including.
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
Drug: Carfilzomib · Drug: Venetoclax · Drug: Dexamethasone
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.
Also known as: Kyprolis
Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.
Also known as: Venclexta, ABT-199
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.
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.
Time frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
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.
Time frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
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.
Time frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
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.
Time frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
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.
Time frame: Up to approximately 17 months
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.
Time frame: Up to approximately 17 months
Minimal residual disease (MRD)
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])
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 frame: Up to approximately 17 months
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.
Time frame: Up to approximately 17 months
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 frame: Up to approximately 17 months
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).
Time frame: Up to approximately 17 months
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
AUC0-24 post-dose of venetoclax.
Time frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Clearance (CL) of Carfilzomib
CL of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Terminal Phase Elimination Rate Constant (β) of Carfilzomib
β of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
AUC from 0 to Infinity (AUC∞) of Carfilzomib
AUC∞ of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib
AUCt of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Maximum Plasma Concentration (Cmax) of Venetoclax
Cmax of venetoclax.
Time frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Cmax of Carfilzomib
Cmax of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Terminal Elimination Half-life (t1/2) of Carfilzomib
t1/2 of carfilzomib.
Time frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax
(Peak time, Tmax) of venetoclax.
Time frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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