Neoplasms

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Blood and Lymph Conditions

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Plasmacytoma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

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Anticoagulants

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Dexamethasone

Lenalidomide

Dexamethasone acetate

Citric Acid

Sodium Citrate

Zoledronic Acid

Ixazomib

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Hormones

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Antineoplastic Agents, Hormonal

Immunologic Factors

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Citrate

Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.

Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.

ixazomib

lenalidomide

dexamethasone

zoledronic acid

Anuj Mahindra, MD

This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.

This phase III randomized clinical trial was designed to assess the impact of the addition of ixazomib, lenalidomide, and dexamethasone to zoledronic acid the multiple myeloma progression rate at 5 years. A dynamic allocation procedure will be used to allocate an equal number of patients to each of the treatment arms. This procedure will balance the number of patients which falls into each of the following categories between the two treatment arms:

1. % of abnormal plasma cells in the bone marrow: 5-9%
2. age \< 60; % of abnormal plasma cells in the bone marrow \< 5%; and monoclonal protein/clonal light chains present in the blood or urine
3. age \< 60; % of abnormal plasma cells in the bone marrow \< 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease
4. age ≥ 60; % of abnormal plasma cells in the bone marrow \< 5%; and monoclonal protein/clonal light chains present in the blood or urine
5. age ≥ 60; % of abnormal plasma cells in the bone marrow \< 5% and no monoclonal protein/clonal light chains present in the blood or urine, (MRD+) minimal residual disease

The primary and secondary objectives are described below.

Primary objective

To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma.

Secondary objectives

1. To assess changes in minimal residual disease \[MRD\] by flow cytometry from study entry, at the completion of treatment, and at 1 year post registration.
2. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival.
3. To examine the pharmacodynamics effects of treatment on biochemical markers of bone formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and metabolism (OPG).

Follow-up requirements after documentation of progression to multiple myeloma includes a maximum of five years following registration.

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone

Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy

National Cancer Institute (NCI)

Millennium Pharmaceuticals, Inc.

Biologics, Inc.

Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for solitary osseous plasmacytoma