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Proteasome Inhibitor

Quadruple Drug Therapy for Multiple Myeloma

Phase 2
Waitlist Available
Led By Elizabeth O'Donnell, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease
Subject must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing an experimental drug combination for people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The drugs involved are: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone.

Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who meet specific health criteria and are eligible for a stem cell transplant. They must have measurable disease, be in relatively good physical condition (ECOG score of 0-2), and agree to use effective contraception. People can't join if they've had certain treatments for multiple myeloma before, active infections like HIV or hepatitis B/C, recent major surgery or radiation therapy, other medical conditions that could affect the study, or if they're pregnant.Check my eligibility
What is being tested?
The trial is testing a new combination of drugs: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone in people with multiple myeloma who can undergo a stem cell transplant. The goal is to see how well this experimental drug mix works against this type of cancer.See study design
What are the potential side effects?
Possible side effects from these drugs include fatigue; increased risk of infection; blood clots; heart issues; allergic reactions; nerve damage leading to numbness or pain; digestive problems like nausea or diarrhea; and blood disorders such as low red cells causing anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have multiple myeloma with symptoms or measurable disease.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I agree to use a condom during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Complete Response (CR + Stringent CR) Rate
Secondary outcome measures
Complete Response Rate in Patients Deferring Stem Cell Transplant
Complete Response Rate in Patients With Upfront Stem Cell Transplant
Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy
+5 more
Other outcome measures
Body composition

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Maintenance-High RiskExperimental Treatment4 Interventions
Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. High Risk: subjects with high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1
Group II: Maintenance- Standard RiskExperimental Treatment1 Intervention
Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. Standard Risk: subjects without high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: - Lenalidomide 10 mg orally (PO) Day 1-21
Group III: InductionExperimental Treatment4 Interventions
All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Carfilzomib
2017
Completed Phase 3
~1440
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,638 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,690 Patients Enrolled for Multiple Myeloma
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
35 Trials studying Multiple Myeloma
2,618 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,430 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,151 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04430894 — Phase 2
Multiple Myeloma Research Study Groups: Induction, Maintenance-High Risk, Maintenance- Standard Risk
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04430894 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04430894 — Phase 2

Frequently Asked Questions

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

To what extent is recruitment for this trial progressing?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is presently seeking participants, which first appeared on the platform in July 10th 2020 and was modified most recently on April 8th 2022. It is looking to recruit 50 candidates between 3 facilities."

Answered by AI

What ailments can be addressed through Carfilzomib treatment?

"Carfilzomib is known to be an effective remedy for ophthalmia, sympathetic and other disorders such as branch retinal vein occlusion, macular edema or prior systemic chemotherapy regimens."

Answered by AI

Is there currently space available for participants in this experiment?

"Affirmative, the information on clinicaltrials.gov affirms that this research endeavor is actively recruiting participants. This experiment was initially launched on July 10th 2020 and has most recently been updated on April 8th 2022. The scope of the study requires 50 recruitments across 3 medical centres."

Answered by AI

Has Carfilzomib been explored in previous research endeavors?

"Presently, there are 717 active research projects researching Carfilzomib with 167 trials in the third stage of clinical development. The town of Mishawaka, Indiana is among 25993 locations across the world running investigations for this medication."

Answered by AI

Does Carfilzomib pose any risks to those who take it?

"The safety of Carfilzomib was rated as a 2 due to being in Phase 2; meaning, while there is evidence for its security, none has been found that conclusively demonstrates efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
KRDI in Transplant-Eligible MM
Elizabeth O'Donnell 2020. "KRDI in Transplant-Eligible MM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430894.
~11 spots leftby Apr 2025
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