Study on Ixazomib with Lenalidomide and Dexamethasone for Treating Multiple Myeloma
Sponsor: Takeda
ClinicalTrials ID:NCT03173092
This clinical trial is testing a combination of three drugs—Ixazomib, Lenalidomide, and Dexamethasone—to see if they can help control Multiple Myeloma in patients who have already received initial treatment with a bortezomib-based regimen.
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Program Overview
The main goal of this study is to see if adding Ixazomib to Lenalidomide and Dexamethasone can help slow down the progression of Multiple Myeloma over two years in patients who have already been treated with a bortezomib-based regimen. About 160 participants will be involved, and they will receive the combination treatment after completing three cycles of initial chemotherapy.
Description
This study is testing a drug called Ixazomib to see if it can help treat Multiple Myeloma (MM) when used with two other drugs, Lenalidomide and Dexamethasone. The study will include about 160 participants who have already completed three cycles of a bortezomib-based treatment and have not shown signs of disease progression. Participants will take Ixazomib, Lenalidomide, and Dexamethasone in 28-day cycles until the disease progresses or side effects become unacceptable, for up to three years. The study will take place in multiple centers across the United States and will last up to 78 months, including time for enrollment and treatment. Participants will visit the clinic regularly and will be monitored for disease progression and overall survival.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of Multiple Myeloma and have received one prior line of therapy.
- Must have completed three cycles of a bortezomib-based induction regimen without disease progression.
- Must be eligible for the IRD regimen as determined by their physician.
- Must be transplant ineligible or not planning to undergo transplant for at least 24 months.
- Must have an ECOG performance status of 0, 1, or 2.
- Female participants must be postmenopausal, surgically sterile, or agree to use two effective methods of contraception.
- Male participants must agree to use effective barrier contraception or practice true abstinence.
Exclusion Criteria
- Participation in other interventional clinical trials within 30 days of this trial.
- Not fully recovered from previous chemotherapy side effects.
- Major surgery within 14 days before enrollment.
- Recent radiotherapy, unless the field is small.
- Central nervous system involvement by Multiple Myeloma.
- Recent serious infection or uncontrolled cardiovascular conditions.
- Recent use of certain medications that affect liver enzymes.
- Active infections like hepatitis B or C, or HIV.
- Recent diagnosis or treatment for another cancer, unless fully resected nonmelanoma skin cancer or carcinoma in situ.
- Significant peripheral neuropathy.
- Previous treatment with Ixazomib or participation in an Ixazomib study.
- Disease progression on first-line therapy.
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