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2-(3-(3,5-Dimethyltriazol-4-Yl)-5-((S)-Oxan-4-Yl(Phenyl)Methyl)Pyrido(3,2-B)Indol-7-Yl)Propan-2-Ol

This article discusses two clinical trials investigating the use of BMS-986158, a novel BET inhibitor, in treating multiple myeloma and myelofibrosis. BMS-986158, also known as 2-(3-(3,5-Dimethyltriazol-4-Yl)-5-((S)-Oxan-4-Yl(Phenyl)Methyl)Pyrido(3,2-B)Indol-7-Yl)Propan-2-Ol, is being studied in combination with other drugs to assess its safety, efficacy, and potential benefits for patients with these challenging blood disorders.

Table of Contents

Introduction

BMS-986158 is an experimental drug being developed by Bristol-Myers Squibb for the treatment of certain blood cancers. This article will provide an overview of what is currently known about this promising new medication based on ongoing clinical trials.[1][2]

What is BMS-986158?

BMS-986158, also known as 2-(3-(3,5-dimethyltriazol-4-yl)-5-((S)-oxan-4-yl(phenyl)methyl)pyrido(3,2-b)indol-7-yl)propan-2-ol, is a new type of drug called a BET inhibitor. It comes in capsule form and is taken orally. BET inhibitors are a class of drugs that work by targeting certain proteins involved in gene regulation.[1][2]

Conditions Treated

BMS-986158 is currently being studied for the treatment of two main conditions:

  • Multiple Myeloma: A type of blood cancer that affects plasma cells in the bone marrow. Specifically, it’s being tested in patients with relapsed or refractory multiple myeloma (RRMM), which means the cancer has returned or is not responding well to other treatments.[1]
  • Myelofibrosis: A rare type of blood cancer that disrupts the body’s normal production of blood cells. The drug is being tested in patients with intermediate or high-risk myelofibrosis, as determined by a scoring system called DIPSS (Dynamic International Prognostic Scoring System).[2]

How It Works

As a BET inhibitor, BMS-986158 works by blocking certain proteins (BET proteins) that play a role in regulating gene expression. In cancer cells, these proteins can sometimes become overactive, leading to uncontrolled cell growth. By inhibiting these proteins, BMS-986158 may help slow or stop the growth of cancer cells.[1][2]

Ongoing Clinical Trials

BMS-986158 is currently being studied in several clinical trials:

  • A Phase 1b/2a study for multiple myeloma, testing BMS-986158 in combination with other drugs like dexamethasone, tazemetostat, and trametinib.[1]
  • A Phase 1b/2 study for myelofibrosis, testing BMS-986158 alone and in combination with drugs like ruxolitinib and fedratinib.[2]

These trials aim to determine the safety, proper dosage, and effectiveness of BMS-986158 in treating these conditions.

Potential Benefits

While it’s still too early to know for sure, researchers hope that BMS-986158 may offer several potential benefits:

  • For multiple myeloma patients, it may help when other treatments have stopped working.[1]
  • For myelofibrosis patients, it might help reduce spleen size and improve symptoms.[2]
  • It may be effective when used alone or in combination with other drugs, potentially offering more treatment options.[1][2]

Side Effects and Safety

As with any new drug, the full range of potential side effects is not yet known. The ongoing clinical trials are carefully monitoring patients for any adverse reactions. Some potential areas of concern being watched include:

  • Effects on blood cell counts
  • Liver function
  • Heart function
  • Gastrointestinal issues

Patients in the trials are closely monitored with regular blood tests and other examinations to ensure their safety.[1][2]

Conclusion

BMS-986158 represents a promising new approach in the treatment of multiple myeloma and myelofibrosis. While still in the experimental stages, it offers hope for patients who may have limited treatment options. As clinical trials progress, more will be learned about its effectiveness and safety profile. Patients interested in this treatment should discuss with their healthcare providers whether participating in a clinical trial might be appropriate for their situation.

Aspect Multiple Myeloma Trial Myelofibrosis Trial
Trial Phase Phase 1b/2a Phase 1b/2
Main Objective Determine safety, tolerability, and RP2D of BMS-986158 combinations Assess safety, tolerability, and determine MTD/RP2D of BMS-986158 combinations
Combination Drugs Dexamethasone, tazemetostat, BMS-986158, trametinib Ruxolitinib, fedratinib
Key Eligibility Relapsed or refractory multiple myeloma, measurable disease DIPSS-Intermediate or High Risk Myelofibrosis, spleen volume ≥ 450 cm3
Primary Endpoints Safety, RP2D Safety, MTD/RP2D
Secondary Endpoints ORR, CRR, PFS, TTR, DOR SVR, symptom response, anemia improvement, PK, SDPFS

FAQ

  • What is BMS-986158? BMS-986158 is a novel BET inhibitor being investigated for the treatment of multiple myeloma and myelofibrosis. It is a chemical compound that targets specific proteins involved in cancer growth.
  • What conditions are being studied in these clinical trials? The clinical trials are focusing on relapsed or refractory multiple myeloma (RRMM) and DIPSS-Intermediate or High Risk Myelofibrosis.
  • How is BMS-986158 being administered in these trials? BMS-986158 is being administered orally in the form of capsules. It is being studied both as a monotherapy and in combination with other drugs such as dexamethasone, ruxolitinib, and fedratinib.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety and tolerability of BMS-986158, determining the recommended Phase 2 dose (RP2D), and evaluating its preliminary efficacy in treating multiple myeloma and myelofibrosis.
  • How is the effectiveness of BMS-986158 being measured in these trials? Effectiveness is being measured through various endpoints, including overall response rate, progression-free survival, spleen volume reduction, and improvement in disease-related symptoms.

Ongoing Clinical Trials on 2-(3-(3,5-Dimethyltriazol-4-Yl)-5-((S)-Oxan-4-Yl(Phenyl)Methyl)Pyrido(3,2-B)Indol-7-Yl)Propan-2-Ol

  • Study on the Safety and Effects of CC-92480 with Dexamethasone and Drug Combinations for Patients with Relapsed or Refractory Multiple Myeloma

    Recruiting

    1 1 1 1
    Investigated drugs:
    Norway Spain

  • Study of BMS-986158 Alone and with Ruxolitinib or Fedratinib for Patients with Intermediate or High Risk Myelofibrosis

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Poland Romania +1

Glossary

  • BET inhibitor: A type of drug that targets and blocks BET (Bromodomain and Extra-Terminal) proteins, which are involved in regulating gene expression and can contribute to cancer growth.
  • Multiple Myeloma: A type of blood cancer that affects plasma cells, a type of white blood cell that normally produces antibodies to fight infections.
  • Myelofibrosis: A rare type of blood cancer where the bone marrow is replaced by scar tissue, leading to problems with blood cell production.
  • Relapsed or Refractory Multiple Myeloma (RRMM): Multiple myeloma that has returned after treatment (relapsed) or does not respond to treatment (refractory).
  • DIPSS: Dynamic International Prognostic Scoring System, a tool used to assess the risk and prognosis of patients with myelofibrosis.
  • Spleen Volume Reduction (SVR): A measure of how much the spleen size decreases in response to treatment, often used as an indicator of effectiveness in myelofibrosis therapies.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be safe and potentially effective, which is then used in larger Phase 2 clinical trials.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-cc-92480-with-dexamethasone-and-drug-combinations-for-patients-with-relapsed-or-refractory-multiple-myeloma/
  2. http://clinicaltrials.eu/trial/study-of-bms-986158-alone-and-with-ruxolitinib-or-fedratinib-for-patients-with-intermediate-or-high-risk-myelofibrosis/