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BMS-986158 + Ruxolitinib/Fedratinib for Myelofibrosis

Phase 1 & 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment

Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month and 12 month

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of BMS-986158 as a treatment for blood cancer. The study will test the drug alone and in combination with two other drugs, Ruxolitinib or Fedratinib.

Who is the study for?

This trial is for adults with a type of blood cancer called myelofibrosis, who are at intermediate or high risk. They must not have unresolved serious side effects from previous treatments and agree to use contraception if needed. Pregnant or breastfeeding women, those with acute illnesses or uncontrolled chronic conditions are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of BMS-986158 alone, and in combination with Ruxolitinib or Fedratinib. Participants will be divided into two parts: one part receiving combinations and the other receiving BMS-986158 alone to compare outcomes.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to cancer medications such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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My side effects from previous treatments have mostly gone away or are stable.

Select...

I have been diagnosed with a type of myelofibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month and 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month and 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month and 12 month 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 AEs leading to discontinuation

Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Incidence of adverse events (AEs)

+2 more

Secondary outcome measures

Additional measures based on TSS measured by MFSAF

For transfusion dependent (TD), proportion of participants becoming TI as measured by the absence of red blood cell (RBC) transfusions over any consecutive 12-week period

For transfusion dependent (TD), proportion of participants becoming Tl as measured by the absence of erythropoiesis stimulating agents (ESA) over any consecutive 12-week period

+12 more

Side effects data

From 2021 Phase 1 & 2 trial • 83 Patients • NCT02419417

100%

Neutropenia

100%

Hypophosphataemia

100%

Dermatitis acneiform

100%

Pruritus

100%

Blood bilirubin increased

100%

Hypocalcaemia

100%

Diarrhoea

100%

Herpes zoster

100%

International normalised ratio increased

100%

Amylase increased

100%

Epistaxis

100%

Leukopenia

100%

Thrombocytopenia

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 Schedule A

Part 1 Schedule B - BMS-986158 3 mg

Part 1 Schedule A - BMS-986158 3 mg

Part 1 Schedule A - BMS-986158 1.25 mg

Part 1 Schedule B - BMS-986158 2 mg

Part 1 Schedule A - BMS-986158 2 mg

Part 1 Schedule A - BMS-986158 4.5 mg

Part 1 Schedule A - BMS-986158 0.75 mg

Part 1 Schedule C - BMS-986158 2 mg

Part 1 Schedule C - BMS-986158 3 mg

Part 1 Schedule C - BMS-986158 4.5 mg

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicableExperimental Treatment2 Interventions

Group II: Part 2B1: BMS-986158 + FedratinibExperimental Treatment2 Interventions

Group III: Part 2A3: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group IV: Part 2A2 Add-On: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group V: Part 2A1: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Group VI: Part 1B: BMS-986158 + FedratinibExperimental Treatment2 Interventions

Group VII: Part 1A: BMS-986158 + RuxolitinibExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986158

2015

Completed Phase 2

~90

Ruxolitinib

2018

Completed Phase 3

~1140

Fedratinib

2019

Completed Phase 1

~190

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,298 Total Patients Enrolled

Media Library

BMS-986158 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04817007 — Phase 1 & 2

Myelofibrosis Research Study Groups: Part 2B1: BMS-986158 + Fedratinib, Part 1B: BMS-986158 + Fedratinib, Part 1A: BMS-986158 + Ruxolitinib, Part 2A3: BMS-986158 + Ruxolitinib, Part 2A2 Add-On: BMS-986158 + Ruxolitinib, Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable, Part 2A1: BMS-986158 + Ruxolitinib

Myelofibrosis Clinical Trial 2023: BMS-986158 Highlights & Side Effects. Trial Name: NCT04817007 — Phase 1 & 2

BMS-986158 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817007 — Phase 1 & 2

Frequently Asked Questions

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

What is the aggregate number of people participating in this trial?

"Affirmative, the data hosted on clinicaltrials.gov affirms that this medical trial has been open since March 2021 and is still actively searching for patients. 192 participants need to be recruited from 12 different sites."

Answered by AI

Are there any previously conducted investigations involving BMS-986158?

"BMS-986158 was first investigated in 2002 at the NIH Clinical Center. Since then, there have been 109 concluded studies and presently 104 active trials that are mainly located around Ann Arbor, Michigan."

Answered by AI

How many health care centers are partaking in this trial?

"The list of approved trial sites includes University Of Michigan in Ann Arbor, Moores Cancer Center-Clinical Trials Office - Hematology in La Jolla, and University of Massachusetts Medical School-Division of Hematology/Oncology in Worcester. Additionally there are 9 other locations hosting this medical research opportunity."

Answered by AI

Are new participants able to join this research endeavor at the present moment?

"As indicated on clinicaltrials.gov, this trial has been actively recruiting since it was initially posted on March 23rd 2021 and is still open for enrollment; the listing was most recently updated in November 8th 2022."

Answered by AI

What diseases does BMS-986158 typically help alleviate?

"BMS-986158 has the potential to treat steroid refractory cases, as well as disorders such as graft-vs-host disease, non-immunocompromised ailments, and intermediate level 2 International Prognostic Scoring System risks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

2021. "A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817007.

All > Blood Cancer > Myelofibrosis