Other

BMS-986158 for Myelofibrosis

Local Institution - 0032, Wollongong, Australia

BMS-986158 +2 morePhase 1 & 2RecruitingResearch Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up6 month and 12 month

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

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.

Eligible Conditions

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%

Fatigue

75%

Diarrhoea

50%

Weight decreased

50%

Back pain

50%

Thrombocytopenia

50%

Decreased appetite

50%

Dizziness

50%

Dysgeusia

50%

Insomnia

50%

Cough

50%

Dyspnoea

25%

Anaemia

25%

Femur fracture

25%

Pathological fracture

25%

Tachycardia

25%

Constipation

25%

Dry mouth

25%

Nausea

25%

Early satiety

25%

Influenza like illness

25%

Mucosal inflammation

25%

Pain

25%

Upper respiratory tract infection

25%

Urinary tract infection

25%

Viral infection

25%

Viral upper respiratory tract infection

25%

Contusion

25%

Radiation retinopathy

25%

Dehydration

25%

Neuropathy peripheral

25%

Pain in extremity

25%

Headache

25%

Parosmia

25%

Epistaxis

25%

Dermatitis acneiform

25%

Pruritus

25%

Hot flush

25%

Sepsis

25%

Flatulence

25%

Gingival pain

25%

Dyspepsia

25%

Enteritis infectious

25%

Urosepsis

25%

Presyncope

25%

Flushing

25%

Abdominal pain upper

25%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Part 1 Schedule B - BMS-986158 2 mg

Part 1 Schedule B - BMS-986158 3 mg

Part 1 Schedule A - BMS-986158 1.25 mg

Part 1 Schedule A - BMS-986158 3 mg

Part 2 Schedule A

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

Not yet FDA approved

Ruxolitinib

FDA approved

Fedratinib

FDA approved

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,562 Previous Clinical Trials

4,029,830 Total Patients Enrolled

Media Library

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

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