TriangleNCT02516423 · STUDY IN CONTEXT
Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies
MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- trial label
- Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0000
- source section id
- NCT02516423-om-0000
- source outcome index
- 0
- endpoint
- Symptomatic Myeloma Progression Free-survival (PFS) Rate
- endpoint definition
- Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies
- time origin
- 18 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who began protocol treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0001
- source section id
- NCT02516423-om-0001
- source outcome index
- 1
- endpoint
- 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
- endpoint definition
- MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.
- time origin
- at 6 and 12 months post-registration
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients. In this study, per protocol, flow cytometry was to be performed by the central lab; early study closure and subsequent lack of funding resulted in no samples being processed by the lab, and therefore minimal residual disease at 6 and 12 months post RT was not collected. Changes in minimal residual disease cannot be reported because minimum residual disease was not collected and will never be collected in the future.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02516423-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Zoledronic Acid
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02516423-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
- regimen
- 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.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02516423-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Zoledronic Acid
- regimen
- 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.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02516423-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- harm key
- EG000
- source section id
- NCT02516423-ae
- event group key
- EG000
- event group label
- Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 0
- collection period
- 5 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02516423
- harm key
- EG001
- source section id
- NCT02516423-ae
- event group key
- EG001
- event group label
- Zoledronic Acid
- serious affected
- 1
- serious at risk
- 6
- other affected
- 5
- other at risk
- 6
- frequency threshold
- 0
- collection period
- 5 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice