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Multiple MyelomaPhase 2NCT02899052

Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

A Phase 2 study testing Carfilzomib, Venetoclax and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 32 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Carfilzomib, Venetoclax and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
32 sitesin 5 countries
Study dates
19 Jan 2017to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 15Show fewer
  • 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

Trial locations and contacts

32 sites in 5 countries.

32 sites in 5 countries

United States18 sites

  • Winship Cancer Institute of Emory University /ID# 161710

    Atlanta, Georgia, 30322

  • Duplicate_University of Maryland School of Medicine /ID# 159721

    Baltimore, Maryland, 21201-1544

  • University of Alabama at Birmingham - Main /ID# 151405

    Birmingham, Alabama, 35233

  • The University of Chicago Medical Center /ID# 151395

    Chicago, Illinois, 60637-1443

  • University of Texas Southwestern Medical Center /ID# 218336

    Dallas, Texas, 75390-7208

  • Duke Cancer Center /ID# 162062

    Durham, North Carolina, 27710-3000

  • Memorial Healthcare System /ID# 224862

    Hollywood, Florida, 33021-3513

  • Indiana Blood & Marrow Transpl /ID# 218862

    Indianapolis, Indiana, 46237

  • Central Maine Medical Center /ID# 218856

    Lewiston, Maine, 04240

  • Duplicate_University of Kentucky Chandler Medical Center /ID# 151407

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences /ID# 151399

    Little Rock, Arkansas, 72205

  • University of Pennsylvania /ID# 151768

    Philadelphia, Pennsylvania, 19104-5502

  • University of Utah /ID# 151397

    Salt Lake City, Utah, 84112-5500

  • Duplicate_VA Puget Sound Healthcare Syst /ID# 155369

    Seattle, Washington, 98108

  • Oncology Hematology Associates (OHA) - Springfield /ID# 218855

    Springfield, Missouri, 65807-5287

  • Washington University-School of Medicine /ID# 222651

    St Louis, Missouri, 63110

  • Baylor Scott & White Medical Center- Temple /ID# 218252

    Temple, Texas, 76508-0001

  • Aurora Health Care, Aurora Cancer Center /ID# 209612

    Wauwatosa, Wisconsin, 53226-3436

Other trials in United States

Australia4 sites

  • Flinders Medical Centre /ID# 221345

    Bedford Park, South Australia, 5042

  • Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200

    East Albury, New South Wales, 2640

  • Royal Hobart Hospital /ID# 217546

    Hobart, Tasmania, 7000

  • Calvary Mater Newcastle /ID# 218739

    Waratah, New South Wales, 2298

Other trials in Australia

Hungary4 sites

  • Semmelweis Egyetem /ID# 217626

    Budapest, 1085

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625

    Budapest, 1097

  • Debreceni Egyetem-Klinikai Kozpont /ID# 217624

    Debrecen, Hajdú-Bihar, 4032

  • Szegedi Tudományegyetem /ID# 219172

    Szeged, 6720

Other trials in Hungary

Spain4 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 218006

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona /ID# 218007

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon /ID# 218005

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal /ID# 220925

    Madrid, 28034

Other trials in Spain

Puerto Rico2 sites

  • Auxilio Mutuo Cancer Center /ID# 157853

    San Juan, 00918

  • VA Caribbean Healthcare System /ID# 157854

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

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

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.

Keywords
Multiple Myeloma, Refractory myeloma, Relapsed myeloma, Relapsed or Refractory
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarfilzomibDrug

    Also called Kyprolis

    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.

  • VenetoclaxDrug

    Also called Venclexta, ABT-199

    Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.

  • DexamethasoneDrug

    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.

Study groups in NCT02899052
Study groupRoleWhat they receive
Venetoclax + Carfilzomib + DexamethasoneExperimentalPart 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
Receives: Drug: Carfilzomib; Drug: Venetoclax; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)

  2. 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.

    Measured: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)

  3. 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.

    Measured: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)

  4. 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.

    Measured: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)

Secondary outcomes (16)

  1. 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.

    Measured: Up to approximately 17 months

  2. 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.

    Measured: Up to approximately 17 months

  3. Minimal residual disease (MRD)

    MRD in the bone marrow by next generation sequencing.

    Measured: Up to 2 years (Screening, Cycle 3 Day 1, and Confirmation of Stringent Complete Response [sCR]/Complete Response [CR])

  4. 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.

    Measured: Up to approximately 17 months

  5. 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.

    Measured: Up to approximately 17 months

  6. 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.

    Measured: Up to approximately 17 months

  7. 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).

    Measured: Up to approximately 17 months

  8. Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax

    AUC0-24 post-dose of venetoclax.

    Measured: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15

  9. Clearance (CL) of Carfilzomib

    CL of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  10. Terminal Phase Elimination Rate Constant (β) of Carfilzomib

    β of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  11. AUC from 0 to Infinity (AUC∞) of Carfilzomib

    AUC∞ of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  12. AUC from Time 0 to the Time of the Last Measurable Concentration (AUCt) of Carfilzomib

    AUCt of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  13. Maximum Plasma Concentration (Cmax) of Venetoclax

    Cmax of venetoclax.

    Measured: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15

  14. Cmax of Carfilzomib

    Cmax of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  15. Terminal Elimination Half-life (t1/2) of Carfilzomib

    t1/2 of carfilzomib.

    Measured: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15

  16. Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax

    (Peak time, Tmax) of venetoclax.

    Measured: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study start19 Jan 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02899052
Sponsor's protocol ID
M15-538
Other IDs
2019-004340-30, 2019
Status last verified
Aug 2025
First submitted
1 Sep 2016
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.
Expanded access
Available

Publications

  • Badawi MA, Engelhardt B, Dobkowska E, Deng R, Kaufman JL, Menon R, Salem AH. Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients. Invest New Drugs. 2024 Dec;42(6):635-643. doi: 10.1007/s10637-024-01471-x. Epub 2024 Oct 10.

    PubMed 39388024

  • 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.

    PubMed 34470049

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carfilzomib, Venetoclax and Dexamethasone in people with Multiple Myeloma, run by AbbVie at 32 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Australia, Hungary, Spain, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899052, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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