Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis

• Status: Completed
• Trial end date: 2018-11-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Dexamethasone; Glycine; Ixazomib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria

• 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