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Histone Deacetylase Inhibitor

BGB-11417 + Dexamethasone + Carfilzomib for Multiple Myeloma

Phase 1 & 2
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants in Part 1 should have failed all other available options including having had ≥ 3 prior lines of therapy including a proteasome inhibitor, IMiD agent, and an anti-CD38 monoclonal antibody
Participants in Part 2 should have had and failed ≥ 1 but ≤ 7 prior lines of therapy and prior treatment with both a proteasome inhibitor and an IMiD agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it is effective and safe in people with multiple myeloma who have not responded to other treatments.

Who is the study for?
This trial is for adults with multiple myeloma who've had at least one but no more than seven prior treatments, including a proteasome inhibitor and an IMiD agent. They must have measurable disease, not be refractory to carfilzomib, and have adequate organ function. Exclusions include uncontrolled diabetes, significant heart issues, certain infections like HIV or hepatitis B/C, amyloidosis, plasma cell leukemia, and others.Check my eligibility
What is being tested?
The study tests BGB-11417 alone and combined with dexamethasone and carfilzomib in patients with multiple myeloma. It has two parts: dose escalation (Part 1) where the safest dose is found by gradually increasing it; then cohort expansion (Part 2) where more people are given this dose to see how well it works.See study design
What are the potential side effects?
Potential side effects may include those common to cancer therapies such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Specific side effects related to each drug will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried at least 3 treatments including proteasome inhibitors, IMiD agents, and anti-CD38 antibodies without success.
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I've had 1-7 treatments for my condition, including proteasome inhibitor and IMiD agent.
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My blood counts and liver/kidney functions are within normal ranges.
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I have been diagnosed with multiple myeloma and have an M-component.
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I can take care of myself and am up and about more than half of my waking hours.
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My multiple myeloma has worsened or not responded to my last treatment.
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My cancer has a specific genetic marker (t(11;14)) identified by a special lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Part 2: Complete Response (CR) or better
+2 more
Secondary outcome measures
Part 1: After steady-state: AUC last,ss
Part 1: After steady-state: Cmax, ss
Part 1: After steady-state: time to reach Cmax (tmax,ss)
+8 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 Cohort ExpansionExperimental Treatment3 Interventions
There will be 5 expansion cohorts to further evaluate the safety and efficacy of BGB-11417
Group II: Part 1 Dose EscalationExperimental Treatment3 Interventions
Dose-escalation and de-escalation to determine maximum tolerated dose (MTD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,647 Total Patients Enrolled

Media Library

Multiple Myeloma Research Study Groups: Part 1 Dose Escalation, Part 2 Cohort Expansion
Multiple Myeloma Clinical Trial 2023: BGB-11417 Highlights & Side Effects. Trial Name: NCT04973605 — Phase 1 & 2
BGB-11417 (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973605 — Phase 1 & 2

Frequently Asked Questions

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

Are there any recorded precedents of Dexamethasone being used for clinical research?

"Dexamethasone was first evaluated at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002 and has since been tested across 1137 trials. Currently, 564 clinical studies are recruiting patients with many of them based out of Milwaukee, WI."

Answered by AI

How many venues is this trial managed from?

"Patients can participate in this medical trial at Medical College of Wisconsin, University of Miami Health System and Maryland Oncology. Additionally, there are 21 other locations across the country that are also offering participation opportunities."

Answered by AI

What clinical issues is Dexamethasone commonly prescribed to alleviate?

"Dexamethasone is prescribed for the management of ophthalmia, sympathetic. Additionally, this medication has been shown to reduce symptoms associated with branch retinal vein occlusion, macular edema, and communicable illnesses."

Answered by AI

Are volunteers being taken into this clinical exploration at present?

"Affirmative. Information available on clinicaltrials.gov corroborates that this medical study, initially published in September 2021, is currently recruiting participants. A total of 167 individuals need to be enrolled from 21 distinct sites."

Answered by AI

How many volunteers are participating in this experiment?

"To conduct the trial, BeiGene requires 167 participants that are eligible under their criteria. Milwaukee's Medical College of Wisconsin and University of Miami Health System in Florida will be two sites hosting this clinical study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma
2021. "A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973605.
~82 spots leftby Nov 2026
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