141 Participants Needed

IRD Regimen for Multiple Myeloma

Recruiting at 44 trial locations
TS
Overseen ByTakeda Study Registration Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Millennium Pharmaceuticals, Inc.
Must be taking: Bortezomib, Lenalidomide, Dexamethasone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The main aim is to evaluate the effect of Ixazomib in combination with lenalidomide and dexamethasone on Multiple Myeloma disease progression at 2 years in participants who previously received a bortezomib-based induction regimen.The study will enroll approximately 160 participants, who are enrolled after completing 3 cycles of chemotherapy (Bortezomib-Based Induction Regimen). They are then treated with Ixazomib in addition to lenalidomide and dexamethasone.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically strong cytochrome P450 3A inducers like rifampin and St. John's wort, at least 14 days before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss with your doctor.

Is the IRD regimen for multiple myeloma safe for humans?

The IRD regimen, which includes ixazomib, lenalidomide, and dexamethasone, has been shown to have a good safety profile in patients with multiple myeloma. Some studies report mild to moderate side effects, such as rash and peripheral neuropathy (nerve damage causing pain or numbness), but these are generally manageable. Serious side effects are rare, and the treatment is considered well-tolerated overall.12345

What makes the IRD drug regimen unique for treating multiple myeloma?

The IRD regimen, which includes ixazomib, lenalidomide, and dexamethasone, is unique because it is an all-oral treatment option that has shown effectiveness and a good safety profile for patients with relapsed or refractory multiple myeloma, offering a convenient alternative to other regimens that may require injections or infusions.12678

What data supports the effectiveness of the drug regimen involving Dexamethasone, Ixazomib, and Lenalidomide for treating multiple myeloma?

Research shows that the combination of Ixazomib, Lenalidomide, and Dexamethasone is effective in treating relapsed and refractory multiple myeloma, with studies reporting significant response rates and improved survival outcomes. This drug regimen has been shown to be well-tolerated and effective even in patients who have undergone multiple previous treatments.126910

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults with Multiple Myeloma who've had a bortezomib-based treatment but no disease progression. They should be ineligible for transplant or not planning one within 24 months, able to perform daily activities (ECOG status 0-2), and agree to use effective contraception.

Inclusion Criteria

Must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.
I can take care of myself and am up and about more than half of my waking hours.
I am a woman who cannot become pregnant or will use two birth control methods during the study.
See 6 more

Exclusion Criteria

I do not have any uncontrolled heart problems.
I haven't taken specific strong medications or herbal supplements like St. John's wort in the last 14 days.
I haven't had any cancer besides nonmelanoma skin cancer or in situ carcinoma, or if I have, it was treated over 2 years ago with no remaining signs.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ixazomib in combination with lenalidomide and dexamethasone in 28-day cycles until disease progression or unacceptable toxicity for up to 3 years

Up to 3 years
Multiple visits as per standard of care

Follow-up

Participants are monitored for progression-free survival and overall survival every 6 months after disease progression

Up to 2 years
Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Ixazomib
  • Lenalidomide
Trial Overview The study tests Ixazomib combined with Lenalidomide and Dexamethasone on patients who have completed prior chemotherapy. It aims to see how this combination affects the progression of Multiple Myeloma over two years in about 160 participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgExperimental Treatment3 Interventions

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

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Millennium Pharmaceuticals, Inc.

Lead Sponsor

Trials
406
Recruited
46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire profile image

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

Takeda

Lead 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

Published Research Related to This Trial

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]
In a study involving 98 relapsed refractory multiple myeloma patients, treatment with lenalidomide plus dexamethasone resulted in a 52% overall response rate, with 49% achieving partial remission and 3% achieving complete remission, despite patients having undergone a median of 5 prior treatments.
The combination therapy not only provided rapid responses but also extended overall survival by nearly six months, demonstrating its efficacy and safety regardless of previous treatments with thalidomide and bortezomib.
Lenalidomide in relapsed refractory myeloma patients: impact of previous response to bortezomib and thalidomide on treatment efficacy. Results of a medical need program in Belgium.Delforge, M., Michiels, A., Doyen, C., et al.[2018]
In a large observational study of 2150 patients with relapsed/refractory multiple myeloma, lenalidomide plus dexamethasone demonstrated a favorable safety profile, with lower incidence rates of neuropathy and infections compared to other treatments like bortezomib and thalidomide.
The study confirmed that lenalidomide's safety profile in a real-world setting is consistent with previous clinical trial data, with no new safety concerns identified, although it did show a higher incidence of neutropenia compared to bortezomib and thalidomide.
A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide.Gamberi, B., Berthou, C., Hernandez, M., et al.[2021]

Citations

Ixazomib-Thalidomide-Dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma. [2021]
Real-world toxicity and effectiveness of ixazomib, lenalidomide, and dexamethasone in Korean patients with relapsed and/or refractory multiple myeloma. [2023]
Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice. [2021]
Lenalidomide in relapsed refractory myeloma patients: impact of previous response to bortezomib and thalidomide on treatment efficacy. Results of a medical need program in Belgium. [2018]
Ixazomib, lenalidomide, and dexamethasone is effective and well tolerated in multiply relapsed (≥2nd relapse) refractory myeloma: a multicenter real world UK experience. [2021]
Twice-weekly ixazomib in combination with lenalidomide-dexamethasone in patients with newly diagnosed multiple myeloma. [2019]
Real World Efficacy and Safety Results of Ixazomib Lenalidomide and Dexamethasone Combination in Relapsed/Refractory Multiple Myeloma: Data Collected from the Hungarian Ixazomib Named Patient Program. [2020]
A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide. [2021]
Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Ixazomib combined with lenalidomide and dexamethasone chemotherapy for newly diagnosed multiple myeloma in China-Compared with bortezomib/lenalidomide/dexamethasone. [2023]
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