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NCT01351623

Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

Completed Phase 2 Results posted Last updated 13 April 2017
What this trial tests

Phase 2 trial testing Carfilzomib in Multiple Myeloma in 44 participants. Completed in 26 January 2016.

Timeline
9 May 2011
Primary endpoint
26 January 2016
26 January 2016

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment44
Start date9 May 2011
Primary completion26 January 2016
Estimated completion26 January 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Evaluate the Best Overall Response Rate (ORR) Primary · 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions

GroupValue95% CI
Carfilzomib1
Carfilzomib8
Carfilzomib9
Carfilzomib3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Carfilzomib
Serious: 28/44 (64%)
Deaths:

Serious adverse events (27 terms)

ReactionSystemCarfilzomib
Lung infectionRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Platelet count decreasedBlood and lymphatic system disorders
Acute kidney injuryRenal and urinary disorders
Death NOSBlood and lymphatic system disorders
HypertensionCardiac disorders
Pulmonary edemaRespiratory, thoracic and mediastinal disorders
AnemiaBlood and lymphatic system disorders
Heart failureCardiac disorders
Infections and infestations - OtherInfections and infestations
Respiratory failureRespiratory, thoracic and mediastinal disorders
Blood and lymphatic system disorders - Other, specBlood and lymphatic system disorders
Febrile neutropeniaBlood and lymphatic system disorders
HypercalcemiaBlood and lymphatic system disorders
HyperkalemiaBlood and lymphatic system disorders
HypotensionCardiac disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
SepsisInfections and infestations
Upper respiratory infectionInfections and infestations
Abdominal InfectionInfections and infestations
AppendicitisGastrointestinal disorders
Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders
Chest pain - cardiacCardiac disorders
ConfusionPsychiatric disorders
DiarrheaGastrointestinal disorders
Other adverse events (24 terms — click to expand)

ReactionSystemCarfilzomib
DiarrheaGastrointestinal disorders
NauseaGeneral disorders
FatigueGeneral disorders
HeadacheGeneral disorders
ConstipationGastrointestinal disorders
LymphopeniaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders
Peripheral edemaCardiac disorders
ThrombocytopeniaBlood and lymphatic system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
RashSkin and subcutaneous tissue disorders
ArthralgiaGeneral disorders
AnemiaBlood and lymphatic system disorders
HypertensionCardiac disorders
Heart failureCardiac disorders
NeutropeniaBlood and lymphatic system disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
HypophosphatemiaBlood and lymphatic system disorders
HyponatremiaBlood and lymphatic system disorders
HypocalcemiaBlood and lymphatic system disorders
ALT increasedHepatobiliary disorders
AST increasedHepatobiliary disorders
HyperglycemiaMetabolism and nutrition disorders

Most-reported serious reactions: Lung infection, Dyspnea, Platelet count decreased, Acute kidney injury, Death NOS, Hypertension, Pulmonary edema, Anemia.

Data from ClinicalTrials.gov NCT01351623 adverse events section.

Sponsor's own description

The purpose of this study is to test a new drug called carfilzomib. It is a type of drug called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells make a lot of protein and are especially in need of a functional proteasome to survive. Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It is considered an experimental drug. Previous studies have shown that carfilzomib is safe to use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A phase 2 single-center study of carfilzomib 56 mg/m2 with or without low-dose dexamethasone in relapsed multiple myeloma.
    Lendvai N, Hilden P, Devlin S, Landau H, et al · · 2014 · cited 66× · PMID 24963043 · DOI 10.1182/blood-2014-02-556308
  2. Predictive biomarkers and practical considerations in the management of carfilzomib-associated cardiotoxicity.
    Lendvai N, Tsakos I, Devlin SM, Schaffer WL, et al · · 2018 · cited 16× · PMID 29308691 · DOI 10.1080/10428194.2017.1403020
  3. Relapsed and refractory lymphoid neoplasms and multiple myeloma with a focus on carfilzomib.
    Nooka A, Gleason C, Casbourne D, Lonial S. · · 2013 · cited 13× · PMID 23386784 · DOI 10.2147/btt.s24580
  4. The future of proteasome inhibitors in relapsed/refractory multiple myeloma.
    Orlowski RZ. · · 2011 · cited 1× · PMID 25188482
  5. Rediscovering hemostasis abnormalities in multiple myeloma: The new era.
    Huang Y, Wang C, Wang H, Liu H, et al · · 2024 · PMID 39055831 · DOI 10.1016/j.heliyon.2024.e34111

Verify or expand the search:

Other trials of Carfilzomib

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01351623.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing