Clinical Trial: Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite
Brief Summary: 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.
Detailed Summary:
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:
- % of abnormal plasma cells in the bone marrow: 5-9%
- age < 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine
- 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
- age ≥ 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal protein/clonal light chains present in the blood or urine
- 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
- To assess change
Sponsor: Alliance for Clinical Trials in Oncology
Current Primary Outcome: Progression-free survival rate [ Time Frame: at 5 years ]
Original Primary Outcome: Progression free-survival [ Time Frame: Up to 5 years ]
Current Secondary Outcome:
- Changes in minimal residual disease from study entry to the completion of adjuvant treatment (approximately six months post-registration) and at 1 year post-registration [ Time Frame: at 6 and 12 months post-registration ]
- Clinical response rate at 12 months post-registration using whole body PET/CT [ Time Frame: at 12 months post-registration ]
Original Secondary Outcome:
- Changes in minimal residual disease from study entry, to the completion of adjuvant treatment [ Time Frame: Up to 1 year post-registration ]
- Clinical response rate at 12 months post-registration using whole body PET/CT [ Time Frame: Up to 12 months ]
- Overall survival [ Time Frame: Up to 5 years ]
Information By: Alliance for Clinical Trials in Oncology
Dates:
Date Received: August 4, 2015
Date Started: December 2015
Date Completion:
Last Updated: May 24, 2017
Last Verified: May 2017
