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Proteasome Inhibitor

Quad Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Andrew J Yee, MD

Research Sponsored by Andrew Yee, MD

Eligibility Criteria Checklist

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

Must have

Previously treated relapsed and refractory multiple myeloma with specific prior therapy and disease progression criteria

Ability to swallow capsules whole

Must not have

Peripheral neuropathy, hypersensitivity, and recent stem cell transplant

Recent chemotherapy or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization to the disease progression or death from any cause up 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the combination of daratumumab with carfilzomib, pomalidomide, and dexamethasone to see how well it works in treating patients with relapsed or refractory multiple myeloma.

Who is the study for?

This trial is for adults aged 18-80 with relapsed or treatment-resistant multiple myeloma, who have undergone specific prior therapies and show disease progression. Participants must be able to take oral medication, have adequate organ function, agree to use birth control if applicable, and not have a history of significant illness or recent major treatments that could interfere with the study.

What is being tested?

The study is testing a combination of two investigational drugs (Carfilzomib and Daratumumab) with two standard care medications (Dexamethasone and Pomalidomide) in patients with multiple myeloma that has returned after treatment or hasn't responded to previous therapy.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood pressure, fatigue, nausea, respiratory issues like coughing or shortness of breath; risk of infections due to lowered immune response; possible impact on liver enzymes leading to liver problems; nerve damage symptoms such as numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma has returned or didn't respond to treatment and has gotten worse.

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I can swallow pills without any issues.

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I have been diagnosed with multiple myeloma and meet specific protein criteria.

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I am between 18 and 80 years old.

Exclusion Criteria

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

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I do not have severe nerve damage, severe allergies, or a recent stem cell transplant.

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I have recently undergone chemotherapy or radiotherapy.

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I have been diagnosed with COPD or asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to the disease progression or death from any cause up 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization to the disease progression or death from any cause up 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to the disease progression or death from any cause up 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate of the daratumumab, carfilzomib, pomalidomide, and dexamethasone combination

Secondary study objectives

Progression-free survival (PFS)

Rate of Minimal residual disease (MRD) negative status

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

44%

Thrombocytopenia

38%

Peripheral sensory neuropathy

38%

Peripheral Sensory Neuropathy

32%

Anaemia

24%

Fatigue

22%

Diarrhoea

17%

Upper respiratory tract infection

17%

Upper Respiratory Tract Infection

16%

Constipation

15%

Asthenia

15%

Insomnia

13%

Cough

11%

Nausea

11%

Pyrexia

11%

Dizziness

11%

Neuralgia

10%

Back Pain

10%

Pneumonia

10%

Back pain

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Hyperglycaemia

Pain in extremity

Pain in Extremity

Paraesthesia

Headache

Bronchitis

Arthralgia

Hypocalcaemia

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Dyspepsia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Abdominal pain

Alanine aminotransferase increased

Nasopharyngitis

Alanine Aminotransferase Increased

Rash

Abdominal pain upper

Hypertension

Abdominal Pain Upper

Hypophosphataemia

Conjunctivitis

Influenza

Aspartate aminotransferase increased

Muscle Spasms

Musculoskeletal Chest Pain

Muscle spasms

Myalgia

Musculoskeletal chest pain

Urinary tract infection

Herpes zoster

Herpes Zoster

Condition aggravated

General physical health deterioration

Weight decreased

Hyponatraemia

Pulmonary Embolism

Nasal congestion

Weight Decreased

Myocardial infarction

Dehydration

Myocardial Infarction

Pulmonary embolism

Sepsis

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

Orthostatic hypotension

Syncope

Lower respiratory tract infection

Respiratory failure

Chills

Gastroenteritis

Productive cough

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Bortezomib + Dexamethasone (Vd)

Daratumumab + Bortezomib and Dexamethasone (DVd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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: Daratumumab,Carfilzomib, Pomalidomide and DexamethasoneExperimental Treatment4 Interventions

Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. Participants will receive daratumumab, carfilzomib, pomalidomide, and dexamethasone on a 28 day schedule. * Daratumumab will be given according to cycle and dosage determined by protocol. * Carfilzomib will be given at 56 mg/m2 on days 1, 8, 15 (except for C1D1 where it is 20 mg/m2) * Pomalidomide will be given daily on days 1-21. * Dexamethasone will be given weekly, split over two days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide

2011

Completed Phase 2

~1060

Carfilzomib

2017

Completed Phase 3

~1430