All > Toronto > Colorado

Carfilzomib for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorado Blood Cancer Institute, Denver, COMultiple MyelomaCarfilzomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing isatuximab given with carfilzomib, with or without dexamethasone and lenalidomide, to see what effects, good and bad, it has in treating patients with multiple myeloma that has come back or did not respond to previous treatment.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
dexamethasone
1
MDM2 Inhibitor KRT-232
1
Venetoclax MTD with Dexamethasone

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: assessed at 1, 2, and 3 years from start of treatment

Day 28
ARM I: Maximum tolerated dose (MTD) of isatuximab
Day 30
Changes in pharmacodynamics variables as they relate to dose, response, and toxicity of carfilzomib in combination with isatuximab
Day 15
ARM I: Pharmacokinetic (PK) profile of isatuximab
Up to 1 year
ARM I: Incidence of isatuximab-specific antidrug antibodies (ADA)
Day 30
ARM I: Percentage of bone marrow cells expressing cell surface determinant, CD38 and receptor density
Day 60
ARM I: Clinical benefit response (CBR)
ARM I: Incidence of Dose-Limiting Toxicities (DLT)
ARM I: Overall Response Rate (ORR)
ARM II: Overall Response Rate (ORR)
Year 3
Overall survival (OS)
Year 1
Progression Free Survival (PFS)
Time To Progression (TTP)
Day 60
Duration of Response (DOR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
dexamethasone
1
MDM2 Inhibitor KRT-232
1
Venetoclax MTD with Dexamethasone

Trial Design

2 Treatment Groups

Arm II (40 mg dexamethasone, isatuximab, carfilzomib)
1 of 2
Arm I (20 mg dexamethasone, isatuximab, carfilzomib)
1 of 2

Experimental Treatment

89 Total Participants · 2 Treatment Groups

Primary Treatment: Carfilzomib · No Placebo Group · Phase 1

Arm II (40 mg dexamethasone, isatuximab, carfilzomib)Experimental Group · 3 Interventions: Carfilzomib, Isatuximab, Dexamethasone · Intervention Types: Drug, Biological, Drug
Arm I (20 mg dexamethasone, isatuximab, carfilzomib)Experimental Group · 3 Interventions: Carfilzomib, Isatuximab, Dexamethasone · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Isatuximab
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at 1, 2, and 3 years from start of treatment

Who is running the clinical trial?

Thomas Martin, MDLead Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled
2 Trials studying Multiple Myeloma
24 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,301 Previous Clinical Trials
1,330,088 Total Patients Enrolled
95 Trials studying Multiple Myeloma
20,540 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,053 Previous Clinical Trials
2,961,164 Total Patients Enrolled
40 Trials studying Multiple Myeloma
8,716 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older, regardless of your gender.
You have been diagnosed with multiple myeloma and have received treatment for it.
You must have received certain types of medication in the past, and have undergone at least two prior treatment regimens. You can still participate if you have had an autologous bone marrow transplant more than 12 weeks ago. If you have taken carfilzomib, you can still participate if it has been more than 4 weeks since your last dose.
You have received one to three treatments for myeloma before and may not have responded well to lenalidomide but should have responded well to carfilzomib. You can have taken carfilzomib before, but your last treatment must have been at least eight weeks ago.
Your multiple myeloma has either relapsed or is not responding to the current treatment, or you have experienced disease progression within 60 days after the last treatment.
A line of therapy means a full course of treatment without any interruptions due to the cancer getting worse. This includes treatments like stem cell transplantation and maintenance therapy without a break due to the cancer progressing.
You may have received carfilzomib as a treatment before. If you have, it's important to know how your body responded to it and for how long.
You have high levels of M-protein in your blood (equal to or greater than 0.5 g/dL or 5 g/L).
You have high levels of a protein called M-protein in your urine.
Your blood test shows high levels of a specific protein called free light chain and an abnormal ratio of this protein in your blood.
References

Frequently Asked Questions

Has the Food and Drug Administration given its blessing to Carfilzomib?

"Carfilzomib's safety is assessed as a 1 on our rating scale, indicating that there are only limited data points to suggest efficacy and drug security." - Anonymous Online Contributor

Unverified Answer

Are there still openings available to enrollees in this trial?

"Clinicaltrials.gov demonstrates that this healthcare research is still in the recruitment phase, with a first posting date of January 21st 2015 and an edit as recent as July 3rd 2022." - Anonymous Online Contributor

Unverified Answer

What indications is Carfilzomib typically employed to treat?

"Carfilzomib is typically given to those suffering from ophthalmia and sympathetic. This medication can also be used to treat branch retinal vein occlusion, macular edema, as well as communicable illnesses." - Anonymous Online Contributor

Unverified Answer

What other researches have been conducted regarding Carfilzomib?

"Presently, 579 medical trials are underway for Carfilzomib, with 146 of those being in the third stage. A majority of these studies take place near Mishawaka, Indiana; however 19278 other sites around the world have clinical research projects dedicated to this drug's efficacy." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor being implemented in various healthcare establishments across the US?

"This research project is being administered at a quartet of clinical sites, such as the University of California in San Francisco, Icahn School of Medicine situated in New York City, Hackensack University Medical Center located near Hackensack and 4 other associated medical facilities." - Anonymous Online Contributor

Unverified Answer

What is the current size of this trial's participant base?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is open for recruitment, having first been posted on January 21st 2015 and last updated July 3rd 2022. The research requires 89 participants to be sourced from four sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top