Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis
Completed · Phase 1
Conditions studied: Light-Chain Amyloidosis
In brief
This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.
Key facts
- Study ID
- NCT01318902
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 27
- Starts
- 2011-04-27
- Expected to finish
- 2018-11-13
- Last updated by the study team
- 2020-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female participants 18 years or older
- Biopsy-proven systemic relapsed or refractory light-chain (AL) amyloidosis, which after at least 1 prior therapy, in the investigator's opinion, requires further treatment
- If received stem cell transplant, must be at least 3 months posttransplantation and recovered from side effects
- Must have measurable disease defined as serum differential free light chain concentration ≥ 40 mg/L
- Must have objective measurable organ (heart or kidney) amyloid involvement
- Must have cardiac biomarker risk stage I or II disease
- Must have adequate hematologic, hepatic, and renal function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Female participants who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
- Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
- Voluntary written consent
You may not qualify if…
- Peripheral neuropathy that is greater or equal to Grade 2
- Cardiac status as described in protocol
- Severe diarrhea (≥ Grade 3) not controllable with medication or requires administration of total parenteral nutrition
- Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of MLN9708
- Uncontrolled infection requiring systematic antibiotics
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
- Presence of other active malignancy with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limit, or any completely resected carcinoma in situ
- Female participants who are lactating or pregnant
- Major surgery within 14 days before the first dose of study drug
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Where it is running
- Tufts Medical Center — Boston, Massachusetts, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Mount Sinai Medical Center — New York, New York, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- University Health Network — Toronto, Ontario, Canada
- CHU Limoges, Department of Hematology and Cell Therapy, Reference Center for AL amyloidosis — Limoges, France
- Universitatsklinikum Heidelberg Innere Medizin V; Hamatologie, Onkologie und Rheumatologie — Heidelberg, Germany
- Amyloidosis Research & Treatment Center, Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
Full record on ClinicalTrials.gov
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