← Back to Search

Kinase Inhibitor

Belumosudil for Multiple Myeloma

Phase 1 & 2

Recruiting

Led By Robert Orlowski, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have had a histologically or cytologically confirmed diagnosis of symptomatic multiple myeloma at the time of their initial diagnosis, which requires the presence of specific criteria

Patients must have measurable refractory/relapsed multiple myeloma for which they have received three (3) or more prior lines of therapy with triple class refractory disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial is testing a new drug for multiple myeloma to see if it can help treat relapsed or resistant cases.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory multiple myeloma who've tried at least three treatments and still have measurable disease. They must be in fair to good health (ECOG PS of 0-3 if due to the disease), agree to use contraception, and not be on certain anti-HIV drugs or have other serious illnesses or second cancers.Check my eligibility

What is being tested?

The study is testing Belumosudil mesylate's effectiveness alone and combined with Dexamethasone in two phases. Phase I determines the safest dose, while Phase II checks if that dose can control multiple myeloma symptoms.See study design

What are the potential side effects?

While specific side effects of Belumosudil mesylate aren't listed here, similar medications may cause immune system reactions, fatigue, liver issues, gastrointestinal discomforts like nausea or diarrhea, skin rashes, and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I was diagnosed with multiple myeloma based on a tissue or cell test.

Select...

I have multiple myeloma that didn't respond to 3+ treatments, including 3 types of drugs.

Select...

My blood, liver, heart, and kidney functions are all good, and if I have HIV, my CD4+ count is over 1,000 without anti-retroviral therapy.

Select...

I agree to follow the study's rules for birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Side effects data

From 2014 Phase 2 trial • 8 Patients • NCT02106195

25%

Transaminase increased

13%

Nausea

13%

Vomiting

13%

Pyrexia

13%

Fall

13%

Rib Fracture

13%

Tooth ache

13%

Nephrolithiasis

13%

Anastomotic ulder

13%

Somnolence

13%

Hypokalemia

13%

Anastomotic ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Belumosudil 200 mg PO QD

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 (dose expansion)Experimental Treatment1 Intervention

Phase 2, participants will receive belumosudil mesylate at the recommended dose that was found in Phase 1.

Group II: Phase 1 (dose escalation)Experimental Treatment1 Intervention

Phase 1, the dose of belumosudil mesylate participants receive will depend on when participants join this study. The first group of participants will receive the lowest dose level of belumosudil mesylate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil mesylate

2014

Completed Phase 1

~80

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,438 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,781 Patients Enrolled for Multiple Myeloma

Sanofi US Services, IncUNKNOWN

Robert Orlowski, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Is it possible to apply for this medical experiment today?

"Clinicaltrials.gov's records demonstrate that this clinical trial, initially posted on April 30th 2024 and last updated on October 26th 2023 is not currently seeking participants. However, there are 822 other medical studies actively recruiting patients at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma

2024. "Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105554.