MDM2 Inhibitor KRT-232 for Plasmacytoma

Phase-Based Progress Estimates
Huntsman Cancer Institute/University of Utah, Salt Lake City, UTPlasmacytoma+2 MoreMDM2 Inhibitor KRT-232 - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Plasmacytoma
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: Up to 30 days after last dose

Day 30
Change in laboratory test results (hematology and blood chemistry)
Change in vital sign
Day 30
Overall survival (OS)
Day 30
Progression-free survival (PFS)
Day 30
Complete response
Therapeutic procedure
Minor response
Myeloma response rate
Partial response
Pharmacokinetic profile of MDM2 inhibitor KRT-232
Safety parameters
Serum MIC-1 levels
Stable disease
Stringent complete response
Time to response
Very good partial response

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (AMG 232, carfilzomib, lenalidomide, dexamethasone)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: MDM2 Inhibitor KRT-232 · No Placebo Group · Phase 1

Treatment (AMG 232, carfilzomib, lenalidomide, dexamethasone)Experimental Group · 6 Interventions: MDM2 Inhibitor KRT-232, Carfilzomib, Dexamethasone Sodium Phosphate, Dexamethasone, Navtemadlin, Lenalidomide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Isopropyl alcohol
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after last dose

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,157 Previous Clinical Trials
41,163,641 Total Patients Enrolled
233 Trials studying Plasmacytoma
34,549 Patients Enrolled for Plasmacytoma
Hans C LeePrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
2 Previous Clinical Trials
80 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have taken high doses of corticosteroids within 3 weeks before starting KRT-232 (AMG 232) + KRd, unless the dose is equal to or less than 4mg/day of dexamethasone.
You have not received any cancer treatments like chemotherapy, targeted therapy, or investigational drugs for at least 21 days before starting the study drug KRT-232 (AMG 232) + KRd.
You have been diagnosed with multiple myeloma through a tissue sample.
You have high levels of a specific protein called M-protein in your blood.
You have high levels of a protein called M-protein in your urine.
You have abnormal levels of free light chains in your blood.
You have an increase in the protein levels in your blood or urine or a significant difference in the levels of certain molecules in your blood.
You have new bone or soft tissue growths or existing growths that have gotten bigger.
Your blood has too much calcium that is caused by the cancer.
You have received one to three rounds of treatment for your disease. If you had multiple myeloma during this period, it should not have worsened.

Frequently Asked Questions

Are there vacancies within this clinical experiment for new participants?

"According to the 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. Records hosted on 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." - 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.