Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).

Key facts

Study ID

NCT01383928

Run by

Millennium Pharmaceuticals, Inc.

People needed

64

Starts

2011-10-31

Expected to finish

2017-11-27

Last updated by the study team

2019-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Medical Center — Berkeley, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Stanford University — Stanford, California, United States
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Associates of Oncology/Hematology PC — Rockville, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Michigan State University — Lansing, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Mercy St Anne Hospital — Toledo, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• SCRI Tennessee Oncology Nashville — Nashville, Tennessee, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• Virginia Cancer Care Specialist — Fairfax, Virginia, United States
• Virginia Cancer Specialists PC — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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