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Alkylating Agent
Carfilzomib for Multiple Myeloma (BuMelCarAuto Trial)
Phase 1 & 2
Waitlist Available
Led By Patrick Stiff, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
BuMelCarAuto Trial Summary
This trial is testing whether a combination of drugs is an effective preparative regimen for people with multiple myeloma who are candidates for autologous stem cell transplantation. The combination being tested is busulfan and melphalan with carfilzomib. They will compare the results to historical controls of people treated with melphalan, busulfan and bortezomib.
Eligible Conditions
- Multiple Myeloma
BuMelCarAuto Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
36 participants evaluated for safety with treatment-related adverse events and grading by using CTCAE v4.0.
36 participants evaluated for tolerability with treatment-related adverse events and grading by using CTCAE v4.0.
Secondary outcome measures
36 participants evaluated by a physical exam to assess peripheral neuropathy and grading by using CTCAE v4.0.
36 participants evaluated by oral exam to assess mucositis events and grading levels by using CTCAE v4.0.
36 participants evaluated by the liver to assess Veno-occlusive disease and grading levels by using CTCAE v4.0.
+7 moreSide effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
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
BuMelCarAuto Trial Design
5Treatment groups
Experimental Treatment
Group I: Carfilzomib IV at dose: 56 mg/m2Experimental Treatment3 Interventions
The participants will receive Carfilzomib IV at dose: 56 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Group II: Carfilzomib IV at dose: 45 mg/m2Experimental Treatment3 Interventions
The participants will receive Carfilzomib IV at dose: 45 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Group III: Carfilzomib IV at dose: 36 mg/m2Experimental Treatment3 Interventions
The participants will receive Carfilzomib IV at dose: 36 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Group IV: Carfilzomib IV at dose: 27 mg/m2Experimental Treatment3 Interventions
The participants will receive Carfilzomib IV at dose: 27 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
Group V: Carfilzomib IV at dose: 20 mg/m2Experimental Treatment3 Interventions
The participants will receive Carfilzomib IV at dose: 20 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and Granulocyte-Colony stimulating factor (G-CSF) given daily until engraftment occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,898 Total Patients Enrolled
1 Trials studying Multiple Myeloma
3 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,652 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,704 Patients Enrolled for Multiple Myeloma
Patrick Stiff, MDPrincipal Investigator - Loyola University
Loyola University Medical Center, St. Joseph Regional Medical Center
Loyola University Of Chicago Stritch School Of Medicine (Medical School)
Cleveland Clinic Fndn (Residency)
8 Previous Clinical Trials
415 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib IV at dose: 56 mg/m2
- Group 2: Carfilzomib IV at dose: 45 mg/m2
- Group 3: Carfilzomib IV at dose: 20 mg/m2
- Group 4: Carfilzomib IV at dose: 27 mg/m2
- Group 5: Carfilzomib IV at dose: 36 mg/m2
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can be addressed through the use of Carfilzomib?
"Carfilzomib is widely used for allogeneic hematopoietic stem cell transplant and chronic myelogenous leukemia. Additionally, it may be prescribed to aid those suffering from amyloidosis, thrombocythemia, essential, refractory multiple myeloma."
Answered by AI
To what extent is participation being sought for this medical investigation?
"Indeed, clinicaltrials.gov verifies that this trial is actively seeking volunteers for participation. With its initial launch on May 22nd 2019 and latest update on April 23rd 2021, the study currently needs 36 individuals to sign up from a single site."
Answered by AI
Are there any openings available for potential participants in this scientific trial?
"Clinicaltrials.gov confirms that this medical trial is engaging participants, having been first posted on May 22nd 2019 and most recently edited on April 23rd 2021."
Answered by AI
What are the objectives of this research endeavor?
"Amgen, the study sponsor for this trial, has reported that their primary outcome of interest will be assessed over a three-year period. This involves measuring 36 participants' tolerability and any adverse reactions through CTCAE v4.0. Additionally, secondary outcomes including Veno-occlusive disease grading levels by using CTCAE v4.0., urine tests to determine response rates in complete/very good partial/partial no stable disease patients, and blood tests assessing Progression Free Survival are also being monitored during the study's duration."
Answered by AI
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