What is the mechanism of action of this treatment?

Carfilzomib is a proteasome inhibitor that works by blocking the proteasome's function, leading to the accumulation of proteins within cancer cells, which induces cell death. Pomalidomide is an immunomodulatory agent that enhances the immune system's ability to attack cancer cells, inhibits angiogenesis (formation of new blood vessels that feed tumors), and directly induces cancer cell death. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune response, which can help decrease the growth of myeloma cells. These mechanisms are crucial for Multiple Myeloma patients as they target the cancer cells through different pathways, increasing the likelihood of effective treatment and potentially improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as Carfilzomib, Pomalidomide, and Dexamethasone, have distinct side effect profiles. Carfilzomib is associated with a higher incidence of serious infections, particularly lower respiratory tract infections, and can cause thrombocytopenia, anemia, and fatigue. Pomalidomide, an immunomodulatory agent, can lead to cytopenias, fatigue, gastrointestinal issues, and rash. Dexamethasone, a corticosteroid, is known to cause insomnia, hyperglycemia, and increased risk of infections. Combining these agents can enhance efficacy but also increases the likelihood of experiencing these adverse effects.

What prior FDA approvals exist?

Carfilzomib, a proteasome inhibitor, is FDA-approved for the treatment of relapsed or refractory multiple myeloma. Pomalidomide, an immunomodulatory agent, is approved for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Dexamethasone, a corticosteroid, is frequently used in combination with other agents for multiple myeloma treatment. Other related FDA-approved drugs include Bortezomib, another proteasome inhibitor, and Lenalidomide, another immunomodulatory agent, both of which are used for similar indications in multiple myeloma treatment.

What other types of research exist?

Promising novel alternatives for Multiple Myeloma treatment include: <ol> <li>Teclistamab - A bispecific antibody targeting BCMA and CD3, showing efficacy in relapsed or refractory multiple myeloma.</li> <li>Belantamab Mafodotin - An antibody-drug conjugate targeting BCMA, effective in relapsed or refractory cases.</li> <li>Selinexor - A selective inhibitor of nuclear export, used in combination with bortezomib and dexamethasone, showing improved outcomes.</li> <li>Isatuximab - An anti-CD38 monoclonal antibody, used in combination therapies for relapsed multiple myeloma.</li> <li>Elotuzumab - An anti-SLAMF7 monoclonal antibody, combined with lenalidomide and dexamethasone, effective in relapsed/refractory multiple myeloma.</li> </ol>

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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

Must not have

Primary refractory multiple myeloma

Prior treatment with pomalidomide

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

No Placebo-Only Group

Summary

This trial uses a combination of three drugs to treat adults with multiple myeloma whose cancer has returned and did not respond to previous treatment. The treatment works by stopping cancer growth, boosting the immune system, and reducing inflammation.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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My condition did not improve after taking lenalidomide.

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I have responded positively to at least one previous cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My multiple myeloma did not respond to initial treatment.

Select...

I have been treated with pomalidomide before.

Select...

I have POEMS syndrome.

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I was diagnosed with amyloidosis linked to myeloma.

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I have been diagnosed with myelodysplastic syndrome.

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I had to stop taking lenalidomide because of its side effects.

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I have been diagnosed with Waldenström macroglobulinemia.

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My blood test shows a high number of plasma cells.

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My condition is IgM subtype multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) (PA DCO Only)

Secondary study objectives

Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC (PA DCO Only)

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%

Hypocalcaemia

16%

Neutrophil count increased

16%

Hypoalbuminaemia

16%

Blood lactate dehydrogenase increased

15%

Blood pressure increased

15%

Blood uric acid increased

15%

Lung infection

14%

Blood bilirubin increased

14%

Hyperglycaemia

14%

White blood cell count increased

14%

Blood glucose increased

14%

Constipation

12%

Neutrophil percentage increased

12%

Blood urea increased

11%

Alanine aminotransferase increased

11%

Hypercalcaemia

11%

Hyponatraemia

10%

Bronchitis

10%

Blood potassium decreased

10%

Oedema peripheral

10%

Neuropathy peripheral

10%

Productive cough

10%

Aspartate aminotransferase increased

10%

Lymphocyte percentage decreased

Leukocytosis

Hypoproteinaemia

Influenza

Blood albumin decreased

Blood phosphorus increased

Peripheral swelling

Back pain

Hypophosphataemia

Mean cell volume increased

Prealbumin decreased

Bilirubin conjugated increased

Vomiting

Abdominal distension

Cataract

Nasopharyngitis

Hypoglycaemia

Gamma-glutamyltransferase increased

Thrombocytopenia

Hyperkalaemia

Hepatic function abnormal

Respiratory tract infection

Nausea

Vision blurred

Plasma cell myeloma

Acute kidney injury

Bone pain

Localised infection

Cardiac amyloidosis

Hypotension

Obstructive airways disorder

Interstitial lung disease

Pleural effusion

Deep vein thrombosis

Myelopathy

Chronic kidney disease

Organising pneumonia

Myolipoma

Neuralgia

Asthma

Lipoma

Cerebral ischaemia

Nerve compression

Disease progression

Infusion site extravasation

Escherichia sepsis

Otitis media

Periodontitis

Pathological fracture

Pain

Device related infection

Dysuria

Soft tissue infection

Spinal compression fracture

Cardiac failure acute

Supraventricular tachycardia

Bronchiolitis

Pancreatitis acute

100%

80%

60%

40%

20%

Study treatment Arm

Carfilzomib With Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Dexamethasone

2007

Completed Phase 4

~2650

Carfilzomib

2017

Completed Phase 3

~1430

Pomalidomide

2011

Completed Phase 2

~1020

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Carfilzomib is a proteasome inhibitor that works by blocking the proteasome's function, leading to the accumulation of proteins within cancer cells, which induces cell death. Pomalidomide is an immunomodulatory agent that enhances the immune system's ability to attack cancer cells, inhibits angiogenesis (formation of new blood vessels that feed tumors), and directly induces cancer cell death. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune response, which can help decrease the growth of myeloma cells. These mechanisms are crucial for Multiple Myeloma patients as they target the cancer cells through different pathways, increasing the likelihood of effective treatment and potentially improving patient outcomes.

Relapsed/Refractory multiple myeloma: defining refractory disease and identifying strategies to overcome resistance.