In short
A new clinical trial is investigating the effectiveness of Inobrodib, when combined with Pomalidomide and Dexamethasone, for patients with multiple myeloma that has returned after treatment or no longer responds to available therapies. This Phase II study aims to evaluate how well this drug combination works against relapsed or refractory multiple myeloma and to further understand potential side effects. The trial is particularly focused on patients who have already tried several other treatments including proteosome inhibitors, anti-CD38 monoclonal antibodies, and targeted immunotherapies, but whose cancer continues to progress.
Key points
- Inobrodib is being tested in a Phase II clinical trial for patients with relapsed or refractory multiple myeloma who have already tried several other treatments. The study combines Inobrodib with two existing drugs, Pomalidomide and Dexamethasone, to evaluate if this three-drug combination can effectively treat myeloma that has become resistant to other therapies. About 100 patients will receive Inobrodib twice daily for 4 days followed by 3 days off, along with standard doses of Pomalidomide and Dexamethasone in 28-day cycles. The main goal is to measure how many patients respond to this treatment combination, with researchers also tracking how long responses last and monitoring for side effects over a period of up to 48 months.
At a glance
- Condition
- Relapsed or Refractory Multiple Myeloma
- Treatment Combination
- Inobrodib + Pomalidomide + Dexamethasone (InoPd)
- Inobrodib Dosing
- 40 mg orally twice daily, 4 days on/3 days off for each 28-day cycle
- Pomalidomide Dosing
- 4 mg orally once daily on Days 1-21 of each 28-day cycle
- Dexamethasone Dosing
- 40 mg orally once daily on Days 1, 8, 15, and 22 of each 28-day cycle
- Participant Eligibility
- 18+ years old; refractory to proteosome inhibitor, anti-CD38 antibody, and pomalidomide; previously treated with targeted immunotherapy
- Number of Participants
- Approximately 100 patients
- Primary Outcome
- Objective Response Rate (ORR) based on IMWG criteria
- Treatment Duration
- Until disease progression, new anticancer therapy, unacceptable toxicity, or withdrawal criteria met
- Study Duration
- Up to 48 months
What is Inobrodib?
Inobrodib (also known as CS1477) is an investigational medicine being studied for the treatment of multiple myeloma that has either come back after previous treatment (relapsed) or no longer responds to available therapies (refractory). Multiple myeloma is a type of blood cancer that affects plasma cells, which are white blood cells that produce antibodies to fight infections.
This drug is currently being evaluated in clinical trials to determine its effectiveness and safety when used in combination with other medications. It is not yet approved for general use and is only available through clinical trials.
Inobrodib Combination Therapy
In the ongoing clinical trial, Inobrodib is not being used alone but as part of a three-drug combination therapy:
- Inobrodib - The investigational drug being studied
- Pomalidomide (also known as Pomalyst or Imnovid) - An established medication for multiple myeloma
- Dexamethasone - A corticosteroid that is commonly used in cancer treatment
This combination is referred to as "InoPd" in the clinical trial documentation. The researchers want to determine if adding Inobrodib to the established combination of pomalidomide and dexamethasone can improve outcomes for patients whose multiple myeloma has stopped responding to other treatments.
Who is Eligible for This Treatment?
The treatment is being studied specifically for patients who meet the following criteria:
- Adults aged 18 years or older
- Diagnosed with multiple myeloma that has relapsed (come back) and become refractory (no longer responds) to previous treatments
- Their cancer must be refractory to at least one proteasome inhibitor (a type of cancer medication that blocks the action of proteasomes, which are cellular complexes that break down proteins)
- Their cancer must be refractory to at least one anti-CD38 monoclonal antibody (a type of targeted therapy that binds to CD38 proteins on myeloma cells)
- Their cancer must be refractory to pomalidomide, even though pomalidomide is included in the study treatment
- They must have previously received an approved targeted immunotherapy such as:
- BCMA therapy (B-cell maturation antigen targeted treatment)
- CAR-T therapy (Chimeric Antigen Receptor T-cell therapy, where a patient's own immune cells are modified to fight cancer)
- GPRC5D therapy (G Protein-Coupled Receptor Class C Group 5 Member D targeted treatment)
- T-cell engagers (TCEs, which help direct T cells to cancer cells)
- Antibody-drug conjugates (ADCs, which combine antibodies with cancer-killing drugs)
These eligibility criteria indicate that Inobrodib is being studied for patients with advanced multiple myeloma who have already tried and not responded adequately to several other treatment options.
How is the Treatment Administered?
The clinical trial uses a specific dosing schedule for each medication in the combination:
- Inobrodib: 40 mg taken orally (by mouth) twice daily, following a schedule of 4 days on and 3 days off, within each 28-day treatment cycle.
- Pomalidomide: 4 mg taken orally once daily on days 1 through 21 of each 28-day cycle.
- Dexamethasone: 40 mg taken orally once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Patients continue receiving this treatment until one of the following occurs:
- Their disease progresses (gets worse)
- They start a different anti-cancer therapy
- They experience unacceptable side effects
- They meet other criteria for withdrawal from the study
Treatment Goals and Effectiveness Measures
The main goal of the treatment is to achieve an objective response in patients with relapsed or refractory multiple myeloma. The trial measures several outcomes to determine how well the treatment works:
- Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment. The researchers are looking for patients to achieve at least a partial response (PR), which means the cancer has decreased by a certain amount.
- Duration of Response (DoR): How long the positive response to treatment lasts.
- Time to Response (TTR): How quickly patients respond to the treatment.
- Very Good Partial Response (VGPR) rate: The percentage of patients who achieve a deeper level of response than just PR.
- Complete Response (CR) rate: The percentage of patients whose cancer becomes undetectable after treatment.
- Progression-Free Survival (PFS): How long patients live without their cancer getting worse.
- Overall Survival (OS): How long patients live after starting the treatment, regardless of whether their cancer responds.
These measurements will be assessed both by the study investigators and by an independent review committee to ensure accuracy and objectivity.
Safety Monitoring
An important aspect of the clinical trial is monitoring the safety of Inobrodib when combined with pomalidomide and dexamethasone. The researchers are tracking:
- Treatment-emergent adverse events (TEAEs): Any new medical problems or worsening of existing conditions that occur after starting treatment.
- Vital signs: Basic health measurements like blood pressure, heart rate, and temperature.
- Laboratory abnormalities: Changes in blood tests that might indicate side effects of treatment.
Safety assessments continue from the start of treatment until 28 days after the end of treatment. This information will help determine whether the benefits of adding Inobrodib to the treatment regimen outweigh any potential risks.