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Proteasome Inhibitor

Carfilzomib Triplet for Multiple Myeloma (SELECT Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS of 0 to 2
Male or female subjects age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 cycle 1 until the pa dco date of 30 november 2022; the median duration of kpd treatment as of the dco was 32.8 weeks.
Awards & highlights

SELECT Trial Summary

This trial is testing a new combination of drugs to treat multiple myeloma.

Who is the study for?
This trial is for adults over 18 with Multiple Myeloma who have relapsed after responding to previous treatments but are now resistant to Lenalidomide. They should be in relatively good health (ECOG PS of 0-2) and have measurable disease indicators. Not eligible if they've had certain related conditions, discontinued Lenalidomide due to toxicity, or previously used Pomalidomide.Check my eligibility
What is being tested?
The study tests a combination treatment for Multiple Myeloma using Carfilzomib, Pomalidomide, and Dexamethasone. It's aimed at those who've relapsed early and are no longer responding to Lenalidomide but have responded well to past therapies including proteasome inhibitors.See study design
What are the potential side effects?
Potential side effects include reactions specific to each drug: Carfilzomib can cause heart or lung problems; Pomalidomide may result in blood clots or birth defects if pregnant; Dexamethasone could lead to mood swings, increased blood sugar levels, and bone weakening.

SELECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and perform daily activities.
Select...
I am 18 years old or older.
Select...
My condition did not improve after taking lenalidomide.
Select...
I have responded positively to at least one previous cancer treatment.

SELECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 cycle 1 until the pa dco date of 30 november 2022; the median duration of kpd treatment as of the dco was 32.8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 cycle 1 until the pa dco date of 30 november 2022; the median duration of kpd treatment as of the dco was 32.8 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) (PA DCO Only)
Secondary outcome measures
Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC
Kaplan-Meier Estimate of Overall Survival
Kaplan-Meier Estimate of Progression Free Survival as Assessed by the IRC
+7 more

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
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

SELECT Trial Design

1Treatment groups
Experimental Treatment
Group I: Carfilzomib combined with pomalidomide and dexamethasoneExperimental Treatment3 Interventions
Carfilzomib, pomalidomide, and dexamethasone (KPd)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,634 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,686 Patients Enrolled for Multiple Myeloma
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,077 Total Patients Enrolled
44 Trials studying Multiple Myeloma
11,291 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04191616 — Phase 2
Multiple Myeloma Research Study Groups: Carfilzomib combined with pomalidomide and dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04191616 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04191616 — Phase 2

Frequently Asked Questions

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

What is the estimated enrolment size for this clinical trial?

"At this moment, enrollment for the trial has closed. Initially posted on August 6th 2020, it was updated lastly on July 15th 2022. If you are searching for alternative medical trials, 807 studies related to multiple myeloma and 579 involving Carfilzomib are currently recruiting patients."

Answered by AI

Do I qualify to partake in this clinical study?

"This clinical trial is seeking 54 individuals with multiple myeloma, aged between 18 and 99. Eligible subjects must have experienced refractoriness to lenalidamide treatment and achieved partial response (PR) from at least one prior line of therapy. Male or female patients are accepted provided they meet the additional criteria stipulated by International Myeloma Working Group: no relapse within the last 60 days; a minimum 6 month carfilzomib-free interval since their most recent dose; first or second relapse of multiple myeloma according to IMWG standards (subjects unresponsive to previous treatments besides carfilzomib can still"

Answered by AI

Has the FDA granted authorization for Carfilzomib?

"Carfilzomib's safety was rated a 2, as there is evidence of its security profile but not yet any indication that it is efficacious."

Answered by AI

What other investigations have researchers conducted on Carfilzomib?

"Presently, Carfilzomib has 579 operational trials of which 146 have reached the third stage. In Mishawaka, Indiana alone there are a plethora of clinical sites running studies for this drug and 18925 locations across all states are participating in these experiments."

Answered by AI

Are older participants welcomed in this investigation?

"This research is open to individuals aged 18 or above and below 99."

Answered by AI

To what conditions is Carfilzomib commonly applied?

"Carfilzomib is typically administered to treat ophthalmia, sympathetic; however, this medication can also be utilized in the management of branch retinal vein occlusion, macular edema and communicable diseases."

Answered by AI

Are there any unfilled opportunities for individuals to participate in this experiment?

"Currently, this study is not enrolling candidates. It was first posted on August 6th 2020 and underwent its most recent edit on July 15th 2022. If you're looking for alternatives, 807 trials recruiting patients with multiple myeloma are currently active along with 579 involving Carfilzomib as a treatment option."

Answered by AI

How many facilities are managing this clinical experiment?

"At present, patients can be enrolled in this trial at 13 different sites across the United States. These include New Haven, Austin and Denver; alongside 10 other locations. Travelling to your nearest participating clinic is recommended so as to reduce the burden of transportation costs if you do decide to partake."

Answered by AI
~12 spots leftby Apr 2025