AL Amyloidosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT01318902

Recruitment Status:

Completed

Sponsor:

Millennium Pharmaceuticals, Inc.

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There are 10 Locations for this study

See Locations Near You

Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University Health Network
Toronto Ontario, M5G 2, Canada
CHU Limoges, Department of Hematology and Cell Therapy, Reference Center for AL amyloidosis
Limoges Cedex , 87042, France
Universitatsklinikum Heidelberg Innere Medizin V; Hamatologie, Onkologie und Rheumatologie
Heidelberg , D-691, Germany
Amyloidosis Research & Treatment Center, Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT01318902

Recruitment Status:

Completed

Sponsor:


Millennium Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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