NCT00075608 · STUDY IN CONTEXT
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
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. 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
Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
Evaluate immune reconstitution based on time to engraftment
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
- nct id
- NCT00075608
- trial label
- 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
- 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.
- 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma
- nct id
- NCT00075608
- outcome key
- om-0000
- source section id
- NCT00075608-om-0000
- source outcome index
- 0
- endpoint
- Feasibility and Tolerability
- endpoint definition
- Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
- time origin
- 3 months after treatment and annually
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data were collected or analyzed due to study termination
- 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
- nct id
- NCT00075608
- outcome key
- om-0001
- source section id
- NCT00075608-om-0001
- source outcome index
- 1
- endpoint
- Response and Durability of Response
- endpoint definition
- Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
- time origin
- 3 months after treatment and annually
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data were collected or analyzed due to study termination
- 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
- nct id
- NCT00075608
- outcome key
- om-0002
- source section id
- NCT00075608-om-0002
- source outcome index
- 2
- endpoint
- Evaluate Immune Reconstitution
- endpoint definition
- Evaluate immune reconstitution based on time to engraftment
- time origin
- 3 months after treatment and annually
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data were collected or analyzed due to study termination
- 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
- nct id
- NCT00075608
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Second Transplant
- regimen
- Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075608-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma
- nct id
- NCT00075608
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 2nd SCT
- regimen
- Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC melphalan: 140-200 mcg/kg IV over two days autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0 peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075608-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma
- nct id
- NCT00075608
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 2nd SCT
- regimen
- Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC melphalan: 140-200 mcg/kg IV over two days autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0 peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075608-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma
- nct id
- NCT00075608
- harm key
- EG000
- source section id
- NCT00075608-ae
- event group key
- EG000
- event group label
- Second Transplant
- serious affected
- 12
- serious at risk
- 12
- other affected
- 12
- other at risk
- 12
- frequency threshold
- 5
- collection period
- 1 year
- event definition
- Adverse events were assessed for up to 1 year.
- 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
Triangle