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Proteasome Inhibitor

Quadruple Therapy for Multiple Myeloma (ADVANCE Trial)

Phase 2
Recruiting
Led By Carl Landgren, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Newly diagnosed patients with histologically confirmed Multiple Myeloma (MM) based on the IMWG diagnostic criteria and measurable disease within the past 4 weeks (or past 8 weeks if patient received pre-study MM therapy) based on specified criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

ADVANCE Trial Summary

This trial is testing whether two different treatments for multiple myeloma are safer and more effective than the current standard of care.

Who is the study for?
Adults aged 18-75 with newly diagnosed Multiple Myeloma, able to perform daily activities (ECOG 0-2), and have good heart, kidney, liver, and blood function. Participants must not have had more than one cycle of prior MM treatment or exposure to certain drugs. They should be free from significant heart disease, uncontrolled diabetes or hypertension, severe lung conditions like COPD, and active infections including HIV and COVID-19.Check my eligibility
What is being tested?
The trial is testing if a combination of carfilzomib, lenalidomide & dexamethasone (KRD) alone or with Daratumumab (KRD+DARA) is safer/more effective for controlling multiple myeloma compared to the standard care combo of lenalidomide, bortezomib & dexamethasone (VRD).See study design
What are the potential side effects?
Possible side effects include allergic reactions due to Diphenhydramine; nerve damage from Bortezomib; infusion-related reactions from Daratumumab; high blood sugar levels from Dexamethasone; increased risk of infection due to Lenalidomide; lung issues related to Montelukast; liver toxicity from Acetaminophen; and heart complications due to Carfilzomib.

ADVANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
Select...
I have been recently diagnosed with Multiple Myeloma.
Select...
I am able to have children, not pregnant, and use birth control.
Select...
My blood, kidney, liver, and heart are functioning well.
Select...
My condition has caused damage to my organs or meets specific criteria for myeloma.
Select...
I can undergo treatments to prevent blood clots.
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I am between 18 and 75 years old.
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I agree to use a latex condom during sex with a female capable of becoming pregnant.

ADVANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Minimal Residual Disease (MRD) Negativity
Secondary outcome measures
Event Free Survival (EFS)
Incidence of treatment related toxicity
Minimal Residual Disease (MRD) Negativity
+4 more

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234
62%
Anaemia
49%
Platelet count decreased
49%
Upper respiratory tract infection
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%
Diarrhoea
17%
Hyperuricaemia
16%
Blood lactate dehydrogenase increased
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
14%
Hyperglycaemia
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Hyponatraemia
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Bronchitis
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Blood albumin decreased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Nasopharyngitis
7%
Bilirubin conjugated increased
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Vision blurred
6%
Nausea
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Hyperkalaemia
6%
Hypoglycaemia
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Hypotension
1%
Dysuria
1%
Pathological fracture
1%
Myelopathy
1%
Nerve compression
1%
Chronic kidney disease
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Spinal compression fracture
1%
Otitis media
1%
Soft tissue infection
1%
Cerebral ischaemia
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
1%
Pain
1%
Bronchiolitis
1%
Device related infection
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

ADVANCE Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C- Carfilzomib, Lenalidomide and Dexamethasone with Daratumumab (DKrd)Experimental Treatment8 Interventions
Participants in this group will receive Carfilzomib, Lenalidomide, Dexamethasone with Daratumumab, Acetaminophen, Diphenhydramine and Montelukast on a 28 day cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.
Group II: Arm B - Carfilzomib, Lenalidomide and Dexamethasone (KRD)Experimental Treatment4 Interventions
Participants in this group will receive Carfilzomib, Lenalidomide and Dexamethasone on a 28 day cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.
Group III: Arm A - Bortezomib, Lenalidomide and Dexamethasone (VRD)Experimental Treatment4 Interventions
Participants in this group will receive Bortezomib, Lenalidomide and Dexamethasone on a 21 day treatment cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
2002
Completed Phase 4
~1170
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Dexamethasone
2007
Completed Phase 4
~2590
Autologous Stem Cell Transplant (ASCT)
2012
Completed Phase 2
~190
Lenalidomide
2005
Completed Phase 3
~1480
Montelukast
2008
Completed Phase 4
~15460
Acetaminophen
2017
Completed Phase 4
~2030
Carfilzomib
2017
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
408,953 Total Patients Enrolled
6 Trials studying Multiple Myeloma
1,111 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,362 Previous Clinical Trials
1,384,965 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,440 Patients Enrolled for Multiple Myeloma
Janssen PharmaceuticalsIndustry Sponsor
78 Previous Clinical Trials
203,253 Total Patients Enrolled
11 Trials studying Multiple Myeloma
426 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04268498 — Phase 2
Multiple Myeloma Research Study Groups: Arm A - Bortezomib, Lenalidomide and Dexamethasone (VRD), Arm C- Carfilzomib, Lenalidomide and Dexamethasone with Daratumumab (DKrd), Arm B - Carfilzomib, Lenalidomide and Dexamethasone (KRD)
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04268498 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268498 — Phase 2

Frequently Asked Questions

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

Are minors being considered for inclusion in the experimental trial?

"This trial is open to individuals aged 18 and over, up until they reach 75 years of age."

Answered by AI

How many individuals are partaking in this clinical research program?

"For the trial to move forward, 306 participants meeting all necessary inclusion criteria must be recruited. Janssen Pharmaceuticals will facilitate this endeavour from their respective sites in Houston and Chicago; MD Anderson Cancer Center and Rush University Medical Centre respectively."

Answered by AI

Has Carfilzomib been sanctioned by the Federal Drug Administration?

"Carfilzomib's safety has been partially assessed through a Phase 2 trial, leading to an estimation of security at level two on the 1-3 scale. No data exists in regards to efficacy yet."

Answered by AI

What other research has been done using Carfilzomib as a therapeutic agent?

"Presently, there are 894 ongoing clinical studies exploring the effects of Carfilzomib with 202 trials in their final phase. Most studies take place in Joliet, Illinois however global participation is strong; over 27 thousand different places have hosted a trial for this medication."

Answered by AI

Could I potentially qualify to participate in this experiment?

"To take part in this clinical trial, potential participants must meet the age criteria of 18-75 and be diagnosed with multiple myeloma. The sheer number of patients that are being admitted is 306."

Answered by AI

Are there a variety of sites conducting this medical experiment in the city?

"This clinical trial is recruiting participants from 11 sites including MD Anderson Cancer Center in Houston, Texas; Rush University Medical Center in Chicago, Illinois; and Stony Brook University in Stony Brook, New york."

Answered by AI

In what cases is Carfilzomib regularly prescribed?

"Carfilzomib is a common medication to manage macular edema, but it can also be beneficial in treating eye inflammation and viral retinal necrosis associated with varicella-zoster. Additionally, Carfilzomib has been used for ulcerative colitis when other treatments have failed."

Answered by AI

Are recruitment efforts ongoing for this experiment?

"Affirmative. Clinicaltrials.gov shows that this medical study, initially posted on February 11th 2020, is still seeking participants. A total of 306 people need to be recruited from 8 distinct sites."

Answered by AI
~125 spots leftby Feb 2027