52 Participants Needed

Ixazomib + Pomalidomide + Dexamethasone for Multiple Myeloma

AS
EB
Overseen ByEmily Benjamin
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Paul Richardson, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have certain treatments like strong CYP3A inducers or inhibitors within 14 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug combination Ixazomib, Pomalidomide, and Dexamethasone for treating multiple myeloma?

Research shows that the combination of Pomalidomide and low-dose Dexamethasone is effective in prolonging survival and improving response rates in patients with relapsed and refractory multiple myeloma. Additionally, a study on the combination of Ixazomib, Pomalidomide, and Dexamethasone found it to be well-tolerated and effective, with nearly half of the patients achieving a partial response or better.12345

Is the combination of Ixazomib, Pomalidomide, and Dexamethasone safe for humans?

The combination of Ixazomib, Pomalidomide, and Dexamethasone has been studied in patients with multiple myeloma and is generally well-tolerated, though some patients experienced serious side effects like fatigue, infections, and low blood cell counts. Pomalidomide and Dexamethasone together have a manageable safety profile, with common side effects including low blood cell counts and infections.12567

What makes the drug combination of Ixazomib, Pomalidomide, and Dexamethasone unique for treating multiple myeloma?

This drug combination is unique because it is an all-oral regimen that combines the first oral proteasome inhibitor, ixazomib, with pomalidomide, an immunomodulatory agent, and dexamethasone, a steroid, offering a convenient and effective treatment option for patients with relapsed or refractory multiple myeloma who have limited treatment choices.12357

Research Team

ON

Omar Nadeem, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have tried at least two therapies, be in decent physical shape (able to perform daily activities), and not have had certain other treatments recently. Women who can get pregnant must follow specific pregnancy testing rules.

Inclusion Criteria

I've had at least two treatments for my condition or one if it included specific drugs and my disease got worse within 60 days after treatment.
Registered into the mandatory POMALYST REMS® program and willing and able to comply with its requirements
I agree to follow the pregnancy testing schedule as required.
See 7 more

Exclusion Criteria

I do not have any health or personal issues that would make it hard for me to follow the study's requirements.
I have a GI condition or had surgery that may affect medication absorption.
I am not pregnant or breastfeeding.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Phase I will follow a standard '3 +3' dose escalation design to test the safety of ixazomib with pomalidomide and dexamethasone

21 days per cycle
3-6 patients per dose level

Phase II Treatment

Single-arm open-label enrollment with dosing based on the MTD determination in Phase I

21 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

Treatment Details

Interventions

  • Dexamethasone
  • Ixazomib
  • Pomalidomide
Trial OverviewThe study tests a combination of three drugs: Ixazomib, Pomalidomide, and Dexamethasone given twice weekly for patients whose Multiple Myeloma has relapsed or is refractory. It's designed to see how safe this mix is and how well it works.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ixazomib plus pomalidomide and dexamethasoneExperimental Treatment3 Interventions
The study drugs will be administered within a 21-day cycle * Phase I will follow a standard "3 +3" dose escalation design: Starting with the first cohort, 3 to 6 patients will be treated at this and each subsequent dose level. * The Phase II portion of the study will be a single-arm open-label enrollment with dosing based on the MTD determination in the Phase I portion of the study

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Dexamethasone for:
  • Inflammation
  • Allergic reactions
  • Respiratory diseases
  • Skin conditions
  • Eye diseases
  • Immune system disorders
🇺🇸
Approved in United States as Dexamethasone for:
  • Inflammatory conditions
  • Allergic states
  • Respiratory diseases
  • Blood disorders
  • Neoplastic diseases
  • Nervous system disorders
🇨🇦
Approved in Canada as Dexamethasone for:
  • Inflammation
  • Allergic reactions
  • Respiratory diseases
  • Skin conditions
  • Eye diseases
🇯🇵
Approved in Japan as Dexamethasone for:
  • Inflammatory conditions
  • Allergic states
  • Respiratory diseases
  • Blood disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

Paul Richardson, MD

Lead Sponsor

Trials
2
Recruited
780+

Paul G. Richardson, MD

Lead Sponsor

Trials
2
Recruited
780+

Omar Nadeem, MD

Lead Sponsor

Trials
3
Recruited
160+

Takeda

Industry Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

Pomalidomide, when combined with low-dose dexamethasone, significantly improves progression-free survival and overall survival in adults with relapsed and refractory multiple myeloma, based on results from multinational phase II and III studies involving patients who had undergone at least two prior treatments.
The treatment has a manageable safety profile, with the most common serious side effects being neutropenia, infections, anemia, and thrombocytopenia, making it a viable option for patients with limited treatment alternatives.
Pomalidomide: A Review in Relapsed and Refractory Multiple Myeloma.Hoy, SM.[2018]
Pomalidomide, combined with low-dose dexamethasone, has been shown to be effective in treating adult patients with relapsed and refractory multiple myeloma, significantly improving progression-free survival and overall response rates compared to high-dose dexamethasone.
The treatment demonstrated a manageable safety profile and was effective across various patient subgroups, including those who were refractory to previous therapies, indicating its potential as a valuable salvage therapy option.
Pomalidomide: a review of its use in patients with recurrent multiple myeloma.Scott, LJ.[2022]
In a study of 90 patients with relapsed/refractory multiple myeloma, the combination of ixazomib, thalidomide, and dexamethasone showed a 51.1% overall response rate, indicating significant efficacy in treating this condition.
The treatment was well tolerated, with rare occurrences of severe toxicities, and ixazomib maintenance therapy improved response depth in 12.4% of patients, suggesting a beneficial long-term effect.
Ixazomib-Thalidomide-Dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma.Ludwig, H., Poenisch, W., Knop, S., et al.[2021]

References

Pomalidomide: A Review in Relapsed and Refractory Multiple Myeloma. [2018]
Pomalidomide: a review of its use in patients with recurrent multiple myeloma. [2022]
Ixazomib-Thalidomide-Dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma. [2021]
Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. [2022]
Phase I/II trial of the oral regimen ixazomib, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma. [2020]
Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial. [2019]
Phase 1/2 trial of ixazomib, cyclophosphamide and dexamethasone in patients with previously untreated symptomatic multiple myeloma. [2019]