TriangleNCT00104650 · STUDY IN CONTEXT
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.
Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.
Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.
Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.
Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.
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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- trial label
- Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0000
- source section id
- NCT00104650-om-0000
- source outcome index
- 0
- endpoint
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13
- endpoint definition
- Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) \< 50 nmol/mmol at week 13.
- time origin
- 13 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0001
- source section id
- NCT00104650-om-0001
- source outcome index
- 1
- endpoint
- uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25
- endpoint definition
- Urinary N-telopeptide (uNTX) corrected by creatinine \< 50 nmol/mmol at week 25.
- time origin
- 25 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0002
- source section id
- NCT00104650-om-0002
- source outcome index
- 2
- endpoint
- Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25
- endpoint definition
- Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- time origin
- Baseline, week 25
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0003
- source section id
- NCT00104650-om-0003
- source outcome index
- 3
- endpoint
- Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol
- endpoint definition
- Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.
- time origin
- Day 1, week 25
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0004
- source section id
- NCT00104650-om-0004
- source outcome index
- 4
- endpoint
- Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol
- endpoint definition
- Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.
- time origin
- Day 1, week 25
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0005
- source section id
- NCT00104650-om-0005
- source outcome index
- 5
- endpoint
- Percent Change of Serum CTX From Baseline to Week 25
- endpoint definition
- Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.
- time origin
- Baseline, week 25
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Bisphosphonate IV Q4W
- regimen
- Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Denosumab 180 mg Q12W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Denosumab 180 mg Q4W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Bisphosphonate IV Q4W
- regimen
- Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Denosumab 180 mg Q12W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Denosumab 180 mg Q4W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Bisphosphonate IV Q4W
- regimen
- Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Denosumab 180 mg Q12W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
- analyzed count
- 25
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Denosumab 180 mg Q4W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Bisphosphonate IV Q4W
- regimen
- Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Denosumab 180 mg Q12W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Denosumab 180 mg Q4W
- regimen
- Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00104650-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- harm key
- EG000
- source section id
- NCT00104650-ae
- event group key
- EG000
- event group label
- Bisphosphonate IV Q4W
- serious affected
- 19
- serious at risk
- 35
- other affected
- 33
- other at risk
- 35
- frequency threshold
- 5
- collection period
- 25 weeks
- event definition
- The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- harm key
- EG001
- source section id
- NCT00104650-ae
- event group key
- EG001
- event group label
- Denosumab 180 mg Q12W
- serious affected
- 16
- serious at risk
- 35
- other affected
- 29
- other at risk
- 35
- frequency threshold
- 5
- collection period
- 25 weeks
- event definition
- The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
- 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-multiple-myeloma-kyprolis-51089b0b
- nct id
- NCT00104650
- harm key
- EG002
- source section id
- NCT00104650-ae
- event group key
- EG002
- event group label
- Denosumab 180 mg Q4W
- serious affected
- 21
- serious at risk
- 38
- other affected
- 29
- other at risk
- 38
- frequency threshold
- 5
- collection period
- 25 weeks
- event definition
- The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
- 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