Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 2:14 AM
Study NCT ID:
NCT02921893
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ixazomib Citrate, Lenalidomide, and Dexamethasone in Treating Patients With POEMS Syndrome
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II 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. Chemotherapy drugs, such as lenalidomide, 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. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving ixazomib citrate, lenalidomide, and dexamethasone may work better in treating patients with POEMS syndrome.
Detailed Description:
PRIMARY OBJECTIVE:
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.
EXPLORATORY 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.
CORRELATIVE RESEARCH OBJECTIVES:
I. 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 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo standard of care autologous stem cell transplant (ASCT) after completing 3 cycles 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 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 36 months.
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.
EXPLORATORY 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.
CORRELATIVE RESEARCH OBJECTIVES:
I. 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 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo standard of care autologous stem cell transplant (ASCT) after completing 3 cycles 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 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 36 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: