Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Male or female patients 18 years or older
- Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
- Measurable disease as specified in study protocol
- Hematologic, liver, and renal function as specified in the study protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse; must also adhere to the guidelines of the lenalidomide pregnancy prevention program
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse AND must adhere to the guidelines of the lenalidomide pregnancy prevention program
- Must be able to take concurrent aspirin 325 mg daily
- Voluntary written consent
Exclusion Criteria
- Peripheral neuropathy that is greater or equal to Grade 2
- Female patients who are lactating or pregnant
- Major surgery or radiotherapy within 14 days before the first dose of study drug
- Uncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drug
- Diarrhea (> Grade 1)
- Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
- Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
- Central nervous system involvement
- Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
- Evidence of current uncontrolled cardiovascular conditions
- Prior or concurrent deep vein thrombosis or pulmonary embolism
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- Known allergy to any of the study medications
- Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption, or tolerance of IXAZOMIB
- Diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
Sites / Locations
- UCSF Medical Center
- City of Hope National Medical Center
- Stanford University
- H Lee Moffitt Cancer Center and Research Institute
- University of Chicago Medical Center
- Associates of Oncology/Hematology PC
- Dana Farber Cancer Institute
- University of Michigan
- Michigan State University
- Hackensack University Medical Center
- Memorial Sloan Kettering Cancer Center
- Mount Sinai Hospital
- Duke University Medical Center
- Ohio State University
- Mercy St Anne Hospital
- Oregon Health and Science University
- SCRI Tennessee Oncology Nashville
- Baylor Sammons Cancer Center
- Virginia Cancer Care Specialist
- Virginia Cancer Specialists PC
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1: Ixazomib 3 mg or 3.7 mg
Phase 2: Ixazomib 3 mg
Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.