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Rationale and design of DUAL study: Doxycycline to Upgrade response in light chain (AL) amyloidosis (DUAL): A phase 2 pilot study of a two-pronged approach of prolonged doxycycline with plasma cell-directed therapy in the treatment of AL amyloidosis.

Publication ,  Journal Article
D'Souza, A; Flynn, K; Chhabra, S; Dhakal, B; Hamadani, M; Jacobsen, K; Pasquini, M; Weihrauch, D; Hari, P
Published in: Contemp Clin Trials Commun
December 2017

Light chain (AL) amyloidosis is a plasma cell neoplasm associated with insoluble fibril deposition from clonal immunoglobulin chains systemically. The disease is associated with high early mortality and morbidity owing to advanced organ deposition as well as lack of proven de-fibrillogenic therapies. Pre-clinical and retrospective clinical data suggests that doxycycline has benefit in AL amyloidosis. The ongoing DUAL study is a single center, open label, phase 2 study in which patients with AL amyloidosis who are undergoing clone-directed therapy for the underlying neoplasm with oral doxycycline given for 1 year to test the hypothesis that prolonged doxycycline use will be safe, feasible, and lead to reduced early mortality in systemic AL amyloidosis and hasten organ amyloid response. Clinical follow up visits will occur at monthly intervals for systemic AL patients and at 3 monthly intervals for localized AL patients. Blood tests will be collected during these time points for hematologic response assessment. Organ testing will be conducted at 3 monthly intervals and radiologic testing will be conducted at 6 monthly intervals. Research blood samples will be collected at baseline, 6 and 12 months. Other correlative studies include matrix metalloproteinases (MMP), tissue inhibitor of metalloproteinases (TIMP) testing and patient-reported outcomes.

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Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

December 2017

Volume

8

Start / End Page

33 / 38

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences
 

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D’Souza, A., Flynn, K., Chhabra, S., Dhakal, B., Hamadani, M., Jacobsen, K., … Hari, P. (2017). Rationale and design of DUAL study: Doxycycline to Upgrade response in light chain (AL) amyloidosis (DUAL): A phase 2 pilot study of a two-pronged approach of prolonged doxycycline with plasma cell-directed therapy in the treatment of AL amyloidosis. Contemp Clin Trials Commun, 8, 33–38. https://doi.org/10.1016/j.conctc.2017.08.012
D’Souza, Anita, Kathryn Flynn, Saurabh Chhabra, Binod Dhakal, Mehdi Hamadani, Kirsten Jacobsen, Marcelo Pasquini, Dorothee Weihrauch, and Parameswaran Hari. “Rationale and design of DUAL study: Doxycycline to Upgrade response in light chain (AL) amyloidosis (DUAL): A phase 2 pilot study of a two-pronged approach of prolonged doxycycline with plasma cell-directed therapy in the treatment of AL amyloidosis.Contemp Clin Trials Commun 8 (December 2017): 33–38. https://doi.org/10.1016/j.conctc.2017.08.012.
Journal cover image

Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

December 2017

Volume

8

Start / End Page

33 / 38

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences