Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone
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|ClinicalTrials.gov Identifier: NCT02516423|
Recruitment Status : Recruiting
First Posted : August 5, 2015
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solitary Osseous Plasmacytoma||Drug: ixazomib Drug: lenalidomide Drug: dexamethasone Drug: zoledronic acid||Phase 3|
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.
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.
- 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.
- To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in extending overall survival.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Radiation Therapy|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||September 2024|
Experimental: ixazomib + lenalidomide + dexamethasone + zoledronic acid
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.
Drug: zoledronic acid
Active Comparator: zoledronic acid
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.
Drug: zoledronic acid
- Progression-free survival rate [ Time Frame: at 5 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516423
|Contact: Anuj Mahindra, MD||858-554-8788||Mahindra.Anuj@scrippshealth.org|
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|Study Chair:||Anuj Mahindra, MD||Scripps Health|