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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
My multiple myeloma has returned or didn't respond to treatment and has gotten worse.
Select...
I can swallow pills without any issues.
Select...
I have been diagnosed with multiple myeloma and meet specific protein criteria.
Select...
I am between 18 and 80 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of dose limiting toxicity grade 4 or higher treatment related
Objective response rate of the daratumumab, carfilzomib, pomalidomide, and dexamethasone combination
Secondary outcome measures
Progression-free survival (PFS)
Rate of Minimal residual disease (MRD) negative status

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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
Carfilzomib
2017
Completed Phase 3
~1440
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,094 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,697 Patients Enrolled for Multiple Myeloma
Andrew Yee, MDLead Sponsor
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Multiple Myeloma
2 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,384,309 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,418 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04176718 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab,Carfilzomib, Pomalidomide and Dexamethasone
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04176718 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176718 — Phase 2

Frequently Asked Questions

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

Has Daratumumab been studied in prior research endeavors?

"As of now, Daratumumab is currently being tested in 629 different studies with 151 trials located at Phase 3. Many studies are taking place within Mishawaka, Indiana; nevertheless, there are an astounding 20265 sites conducting research for this medication."

Answered by AI

Are participants of this experiment limited to those aged 55 or younger?

"Applicants of this trial must be between the ages 18 and 80 to qualify. For those too young or elderly, there are a total of 2520 studies available in their respective age brackets."

Answered by AI

Are there any vacancies available for individuals to participate in this experiment?

"Affirmative. Clinicaltrials.gov data indicates that this medical study, which was initially published on May 18th 2020 is actively recruiting participants. 43 individuals are being sought from 3 research sites at present."

Answered by AI

What do physicians typically employ Daratumumab to combat?

"Oftentimes, daratumumab is utilized to treat ophthalmia and sympathetic disorders. It can also be prescribed for a variety of other conditions such as communicable diseases or branch retinal vein occlusion with macular edema."

Answered by AI

How many participants are being recruited for this clinical investigation?

"Affirmative. Clinicaltrials.gov confirms that this trial is presently enrolling 43 participants from 3 separate medical centres, the first posting of which was on May 18th 2020 and most recently revised October 28th 2021."

Answered by AI

Has Daratumumab been granted regulatory approval by the FDA?

"Our team at Power assessed Daratumumab's safety on a scale from 1 to 3, awarding it a score of 2 due to the promising data collected in its Phase 2 trials. However, no clinical evidence has yet been gathered regarding efficacy."

Answered by AI

Is it possible for me to participate in this investigation?

"This experimental trial is welcoming 43 individuals with multiple myeloma who meet the following prerequisites: between 18 and 80 years of age, ≥200mg monoclonal protein in urine 24 hour electrophoresis, prior therapy including at least two cycles each of lenalidomide and a proteasome inhibitor (either separately or combined), serum monoclonal protein ≥ 0.5g/dL,serum free light chain ≥ 100 mg/L (10mg/dl) as well as an abnormal ratio for kappa to lambda light chains, previously treated relapsed refractory multiple myeloma patients needing one line"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Andrew Yee, MD 2020. "Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04176718.
~9 spots leftby May 2025
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