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Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome

2016-10-03 23:38:21 | BioPortfolio

Summary

This pilot clinical trial studies how well ixazomib citrate, lenalidomide, and dexamethasone work in treating patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.

Description

PRIMARY OBJECTIVES:

I. Normalization of VEGF after 3 cycles of therapy.

SECONDARY OBJECTIVES:

I. Toxicity and safety of the combination of ixazomib citrate (ixazomib), lenalidomide, and dexamethasone.

II. Hematologic response after 3 cycles of therapy. III. Hematologic response rates and/or VEGF response at 12 months. IV. Overall survival.

TERTIARY OBJECTIVES:

I. Improvement of peripheral neuropathy (Overall Neuropathy Limitations Scale [ONLS], Modified Neurological Impairment Score for POEMS [mNIS+7POEMS], and performance score), ascites/effusions, diffusing capacity of the lungs for carbon monoxide (DLCO) after 3 cycles of therapy.

II. Improvement of peripheral neuropathy (ONLS, mNIS+7POEMS, and performance score), ascites/effusions, DLCO, and positron emission tomography (PET)-scan (if abnormal at baseline) at 12 months (both groups) and at 24 and 36 months (group 2 only).

III. Time to VEGF response, hematologic response, and clinical response. IV. Time to VEGF progression, hematologic progression, and clinical progression.

V. Doses delivered will be tabulated to establish tolerance of study drugs. VI. To describe changes in bone biomarkers with treatment of ixazomib, lenalidomide, and dexamethasone.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, lenalidomide PO once daily (QD) on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo standard of care autologous stem cell transplant (ASCT) after completing 3 courses of treatment.

GROUP II: Patients receive ixazomib citrate PO, lenalidomide PO QD, and dexamethasone PO as in Group I. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months and then every 6 months for up to 36 months.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Plasmacytoma

Intervention

Dexamethasone, Ixazomib Citrate, Laboratory Biomarker Analysis, Lenalidomide, Questionnaire Administration

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Not yet recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-03T23:38:21-0400

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