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Proteasome Inhibitor

KRT-232 + Chemotherapy for Multiple Myeloma

Phase 1

Recruiting

Led By Hans C Lee

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have disease that has relapsed and/or refractory after their most recent therapy

Subjects must be willing to undergo myeloma genotyping for TP53 mutation, insertion, or deletion at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last dose

Awards & highlights

Study Summary

This trial is testing the combination of KRT-232, carfilzomib, lenalidomide, and dexamethasone to treat patients with relapsed or refractory multiple myeloma. KRT-232 works by blocking MDM2, a protein needed for cell growth, while the other drugs work to kill or stop the growth of cancer cells in different ways. This combination may work better than previous treatments.

Who is the study for?

This trial is for adults with multiple myeloma that has returned or hasn't responded to treatment. Participants must have completed recent therapy, be willing to undergo genetic testing and provide biopsies, have a life expectancy of at least 3 months, and be able to swallow pills. They can't join if they've had certain treatments, surgeries recently, uncontrolled illnesses, specific heart conditions or infections within a set time frame.Check my eligibility

What is being tested?

The trial tests the safety and optimal dose of KRT-232 (AMG 232) combined with carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma patients. It aims to see if this combination is more effective by blocking proteins essential for cancer cell growth while shrinking tumor size.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased risk of infection; gastrointestinal issues like nausea or diarrhea; blood-related problems including anemia; fatigue; possible liver toxicity; and other common chemotherapy-associated side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened or didn't improve after my last treatment.

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I am willing to have a genetic test for specific changes in my myeloma cells.

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My diagnosis of multiple myeloma is confirmed through tissue analysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in laboratory test results (hematology and blood chemistry)

Change in vital sign

Therapeutic procedure

+1 more

Secondary outcome measures

Complete response

Minor response

Myeloma response rate

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AMG 232, carfilzomib, lenalidomide, dexamethasone)Experimental Treatment8 Interventions

Patients receive MDM2 Inhibitor KRT-232 PO QD on days 1-7, carfilzomib IV over 10-30 minutes on days 1-2, 8-9, and 15-16 of cycles 1-12 and on days 1-2 and 15-16 of cycles 13-18, lenalidomide PO on days 1-21, and dexamethasone PO or dexamethasone sodium phosphate IV on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unexpected toxicity. Patients undergo echocardiography during screening and bone marrow biopsy and aspiration, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Carfilzomib

2017

Completed Phase 3

~1440

Dexamethasone

2007

Completed Phase 4

~2590

Dexamethasone Sodium Phosphate

2017

Completed Phase 4

~140

Echocardiography

2013

Completed Phase 4

~11670

Lenalidomide

2005

Completed Phase 3

~1480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,725 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,091 Patients Enrolled for Multiple Myeloma

Hans C LeePrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

2 Previous Clinical Trials

61 Total Patients Enrolled

1 Trials studying Multiple Myeloma

40 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03031730 — Phase 1

Multiple Myeloma Research Study Groups: Treatment (AMG 232, carfilzomib, lenalidomide, dexamethasone)

Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT03031730 — Phase 1

Frequently Asked Questions

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

Are there vacancies within this clinical experiment for new participants?

"According to the clinicaltrials.gov database, this medical investigation is currently enrolling participants. Having been first published on October 27th 2017 and edited lastly on November 26th 2022, it appears that recruitment is still open."

Answered by AI

How many medical facilities are conducting this experiment?

"Currently, this experiment is registering patients in 5 cities; Austin, San Antonio and Sacramento are among them. To reduce necessitated trips to the trial site, it would be judicious to select a location that's closest to you."

Answered by AI

What is the ultimate objective of this research endeavor?

"This clinical trial intends to gauge the efficacy of MDM2 inhibitor KRT-232 and AMG-232, assessing changes in laboratory test results (hematology and blood chemistry) over a 30 day period. The pharmacokinetic profile of both medications will be analysed with liquid chromatography/tandem mass spectrometric methods, utilizing descriptive statistics such as means, medians, standard deviations etc., along with graphical summaries where appropriate. In addition, overall survival and complete response rates for each drug will be assessed using Kaplan-Meier methods and two sided 95% exact binominal CI respectively."

Answered by AI

Has the U.S. Food and Drug Administration granted its seal of approval to KRT-232, a MDM2 Inhibitor?

"The safety of MDM2 Inhibitor KRT-232 was rated at 1 by our team given the limited data about its efficacy and safety in human studies, as this is a Phase 1 trial."

Answered by AI

What medical conditions is MDM2 Inhibitor KRT-232 commonly used to treat?

"KRT-232 is a MDM2 Inhibitor typically used to treat ophthalmia and sympathetic. Additionally, it can be recommended for treatment of branch retinal vein occlusion, macular edema, and those who have had at least two rounds of systemic chemotherapy."

Answered by AI

Has the efficacy of KRT-232 as a MDM2 Inhibitor been investigated in any prior research?

"Initially examined in 2002, MDM2 Inhibitor KRT-232 has since been studied extensively with a total of 1514 trials conducted. Currently there are 754 ongoing studies on the drug, many based out of Austin, Texas."

Answered by AI

How many individuals are involved in this trial's proceedings?

"Affirmative. Records hosted on clinicaltrials.gov disclose that this experiment, which was first published on October 27th 2017, is still recruiting patients. Approximately 40 participants are required from 5 different medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma

2018. "Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03031730.

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