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

August 1, 2025 updated by: AbbVie

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • East Albury, New South Wales, Australia, 2640
        • Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle /ID# 218739
    • South Australia
      • Bedford, Park, South Australia, Australia, 5042
        • Flinders Medical Centre /ID# 221345
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital /ID# 217546
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 217626
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem /ID# 219172
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 217624
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Auxilio Mutuo Cancer Center /ID# 157853
      • San Juan, Puerto Rico, 00921-3201
        • VA Caribbean Healthcare System /ID# 157854
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 218007
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 218005
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 220925
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 218006
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham - Main /ID# 151405
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences /ID# 151399
    • Florida
      • Hollywood, Florida, United States, 33021-3513
        • Memorial Healthcare System /ID# 224862
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University /ID# 161710
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 151395
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood & Marrow Transpl /ID# 218862
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Duplicate_University of Kentucky Chandler Medical Center /ID# 151407
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center /ID# 218856
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Duplicate_University of Maryland School of Medicine /ID# 159721
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University-School of Medicine /ID# 222651
      • Springfield, Missouri, United States, 65807-5287
        • Oncology Hematology Associates (OHA) - Springfield /ID# 218855
    • North Carolina
      • Durham, North Carolina, United States, 27710-3000
        • Duke Cancer Center /ID# 162062
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 151768
    • Texas
      • Dallas, Texas, United States, 75390-7208
        • University of Texas Southwestern Medical Center /ID# 218336
      • Temple, Texas, United States, 76508-0001
        • Baylor Scott & White Medical Center- Temple /ID# 218252
    • Utah
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 151397
    • Washington
      • Seattle, Washington, United States, 98108
        • Duplicate_VA Puget Sound Healthcare Syst /ID# 155369
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226-3436
        • Aurora Health Care, Aurora Cancer Center /ID# 209612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Venetoclax + Carfilzomib + Dexamethasone

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

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.

Other Names:
  • Kyprolis
Drug: Venetoclax
Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.
Other Names:
  • Venclexta
  • ABT-199
Drug: Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
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
Time Frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
VGPR or better response rate is defined as the percentage of participants with documented VGPR or better based on IMWG criteria.
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
Time Frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
ORR is defined as the percentage of participants with a documented PR or better based on IMWG criteria.
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
Time Frame: First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Complete response or better rate is defined as the percentage of participants with documented CR or better based on IMWG criteria.
First dose of study drug through at least 30 days after end of treatment (approximately 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to approximately 17 months
VGPR or better response rate is defined as the proportion of participants with documented VGPR or better based on IMWG criteria.
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
Time Frame: Up to approximately 17 months
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.
Up to approximately 17 months
Minimal residual disease (MRD)
Time Frame: Up to 2 years (Screening, Cycle 3 Day 1, and Confirmation of Stringent Complete Response [sCR]/Complete Response [CR])
MRD in the bone marrow by next generation sequencing.
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
Time Frame: Up to approximately 17 months
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.
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
Time Frame: Up to approximately 17 months
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.
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
Time Frame: Up to approximately 17 months
ORR is defined as the proportion of participants with documented partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria.
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
Time Frame: Up to approximately 17 months
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).
Up to approximately 17 months
Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) post-dose of Venetoclax
Time Frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
AUC0-24 post-dose of venetoclax.
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Clearance (CL) of Carfilzomib
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
CL of carfilzomib.
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Terminal Phase Elimination Rate Constant (β) of Carfilzomib
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
β of carfilzomib.
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
AUC from 0 to Infinity (AUC∞) of Carfilzomib
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
AUC∞ of carfilzomib.
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
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
AUCt of carfilzomib.
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Maximum Plasma Concentration (Cmax) of Venetoclax
Time Frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Cmax of venetoclax.
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
Cmax of Carfilzomib
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Cmax of carfilzomib.
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Terminal Elimination Half-life (t1/2) of Carfilzomib
Time Frame: Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
t1/2 of carfilzomib.
Approximately 4 hours post-dose on Cycle 1 Days 1 and 15
Time to Maximum Plasma Concentration (Peak Time, Tmax) of Venetoclax
Time Frame: Approximately 24 hours post-dose on Cycle 1 Days 1 and 15
(Peak time, Tmax) of venetoclax.
Approximately 24 hours post-dose on Cycle 1 Days 1 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc; Onyx Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M15-538
  • 2019-004340-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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