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Proteasome Inhibitor

Carfilzomib for Multiple Myeloma

Phase 1

Waitlist Available

Led By Robert Orlowski

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, carfilzomib and panobinostat, in treating patients with multiple myeloma that has come back or is not responding to treatment.

Eligible Conditions

Multiple Myeloma
Plasma Cell Myeloma
Plasmacytosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Maximum tolerated dose (MTD) of the drug combination

Secondary outcome measures

Time to progression

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234

62%

Anaemia

49%

Upper respiratory tract infection

49%

Platelet count decreased

39%

White blood cell count decreased

38%

Hypertension

35%

Hypokalaemia

30%

Neutrophil count decreased

28%

Lymphocyte count decreased

23%

Pneumonia

21%

Cough

19%

Blood creatinine increased

19%

Insomnia

18%

Pyrexia

17%

Hyperuricaemia

17%

Diarrhoea

16%

Hypoalbuminaemia

16%

Hypocalcaemia

16%

Neutrophil count increased

16%

Blood lactate dehydrogenase increased

15%

Blood uric acid increased

15%

Blood pressure increased

15%

Lung infection

14%

Hyperglycaemia

14%

White blood cell count increased

14%

Blood bilirubin increased

14%

Blood glucose increased

14%

Constipation

12%

Blood urea increased

12%

Neutrophil percentage increased

11%

Alanine aminotransferase increased

11%

Hyponatraemia

11%

Hypercalcaemia

10%

Aspartate aminotransferase increased

10%

Blood potassium decreased

10%

Bronchitis

10%

Neuropathy peripheral

10%

Productive cough

10%

Oedema peripheral

10%

Lymphocyte percentage decreased

Leukocytosis

Blood phosphorus increased

Influenza

Blood albumin decreased

Hypoproteinaemia

Prealbumin decreased

Bilirubin conjugated increased

Peripheral swelling

Nasopharyngitis

Hypophosphataemia

Back pain

Abdominal distension

Vomiting

Cataract

Mean cell volume increased

Gamma-glutamyltransferase increased

Hyperkalaemia

Thrombocytopenia

Vision blurred

Respiratory tract infection

Hepatic function abnormal

Nausea

Hypoglycaemia

Plasma cell myeloma

Acute kidney injury

Bone pain

Cardiac amyloidosis

Localised infection

Pain

Periodontitis

Myelopathy

Device related infection

Dysuria

Pleural effusion

Otitis media

Pancreatitis acute

Spinal compression fracture

Lipoma

Cerebral ischaemia

Deep vein thrombosis

Cardiac failure acute

Soft tissue infection

Nerve compression

Chronic kidney disease

Hypotension

Asthma

Bronchiolitis

Pathological fracture

Myolipoma

Neuralgia

Escherichia sepsis

Interstitial lung disease

Obstructive airways disorder

Organising pneumonia

Supraventricular tachycardia

Disease progression

Infusion site extravasation

100%

80%

60%

40%

20%

Study treatment Arm

Carfilzomib With Dexamethasone

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carfilzomib, panobinostat)Experimental Treatment2 Interventions

Participants receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16 and panobinostat PO QD on days 1, 3, 5, 8, 10, and 12 of each course. Courses repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, participants may continue carfilzomib IV on days 1, 2, 15, and 16, and panobinostat PO on days 1, 3, 5, 8, 10, and 12 of each course. If the disease becomes worse, participants can receive carfilzomib on the original dosing schedule (days 1, 2, 8, 9, 15, and 16 of each course).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carfilzomib

2017

Completed Phase 3

~1440

Panobinostat

2011

Completed Phase 3

~1560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,254 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,754 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,619 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,068 Patients Enrolled for Multiple Myeloma

Robert OrlowskiPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

92 Total Patients Enrolled

2 Trials studying Multiple Myeloma

92 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial explore new territory or is it based on pre-existing research?

"Carfilzomib has been under medical scrutiny for a decade. Amgen launched the first Phase 3 trial in 2010 with 4420 participants. Carfilzomib received FDA approval after the first study. Currently, there are 801 cities and 46 countries with active Carfilzomib studies."

Answered by AI

What medical conditions does Carfilzomib usually help ameliorate?

"Carfilzomib provides therapeutic relief for patients with relapsed or refractory multiple myeloma, as well as those with Waldenstrom macroglobulinemia."

Answered by AI

What is the maximum number of people allowed in this trial?

"Unfortunately, this trial is no longer enrolling patients. The listing was first posted on July 28th, 2011 and was updated for the last time on June 29th, 2022. However, there are 826 other trials seeking participants with plasmacytosis and 99 trials for Carfilzomib that are still open."

Answered by AI

Has Carfilzomib been cleared by the FDA?

"Carfilzomib received a safety score of 1 because, at this stage in testing, there is only limited data to support its efficacy and safety."

Answered by AI

If so, could you share the results of any other previous research done on Carfilzomib?

"There are a total of 99 ongoing Carfilzomib studies, 15 of which are in Phase 3. Harrison, New york has the most Carfilzomib trials, however there are 2849 total locations where patients can participate in a study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Panobinostat and Carfilzomib in Treating Participants With Relapsed or Refractory Multiple Myeloma

2011. "Panobinostat and Carfilzomib in Treating Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01301807.