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← Light Chain Deposition Disease

NCT01849783 · STUDY IN CONTEXT

Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.

Participants who have had at least one day of protocol treatment.

→

primary · POSTED

Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Participants who have had at least one day of protocol treatment

→

primary · POSTED

Percentage of participants able to complete the full course of therapy.

Participants who received at least one day of study treatment

→

secondary · POSTED

Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.

Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Mean Change in Quality-Of-Life Indicators Post-Transplant

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-light-chain-deposition-disease
nct id
NCT01849783
qol key
qol-0003
source section id
NCT01849783-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Mean Change in Quality-Of-Life Indicators Post-Transplant
measure definition
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
time frame
Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-light-chain-deposition-disease
nct id
NCT01849783
trial label
Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma
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
4
harms Count
7
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0000
    source section id
    NCT01849783-om-0000
    source outcome index
    0
    endpoint
    Median Progression Free Survival (mPFS)
    endpoint definition
    PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
    time origin
    From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who have had at least one day of protocol treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0001
    source section id
    NCT01849783-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With Serious Treatment-Related Complications
    endpoint definition
    Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
    time origin
    From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who have had at least one day of protocol treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0002
    source section id
    NCT01849783-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants Able to Complete Full Course Therapy
    endpoint definition
    Percentage of participants able to complete the full course of therapy.
    time origin
    Up to 6 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one day of study treatment
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0003
    source section id
    NCT01849783-om-0003
    source outcome index
    3
    endpoint
    Mean Change in Quality-Of-Life Indicators Post-Transplant
    endpoint definition
    Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
    time origin
    Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Autologous Stem Cell Transplant
    regimen
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01849783-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Autologous Stem Cell Transplant
    regimen
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01849783-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Autologous Stem Cell Transplant
    regimen
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
    analyzed count
    41
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01849783-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Autologous Stem Cell Transplant
    regimen
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01849783-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG000
    source section id
    NCT01849783-ae
    event group key
    EG000
    event group label
    D-PACE/Induction
    serious affected
    14
    serious at risk
    41
    other affected
    41
    other at risk
    41
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG001
    source section id
    NCT01849783-ae
    event group key
    EG001
    event group label
    Post D-PACE/Pre-Transplant
    serious affected
    2
    serious at risk
    41
    other affected
    8
    other at risk
    41
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG002
    source section id
    NCT01849783-ae
    event group key
    EG002
    event group label
    Transplant
    serious affected
    8
    serious at risk
    39
    other affected
    38
    other at risk
    39
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG003
    source section id
    NCT01849783-ae
    event group key
    EG003
    event group label
    Post-transplant/Consolidation
    serious affected
    4
    serious at risk
    38
    other affected
    8
    other at risk
    38
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG004
    source section id
    NCT01849783-ae
    event group key
    EG004
    event group label
    Maintenance Therapy, Year 1
    serious affected
    11
    serious at risk
    37
    other affected
    27
    other at risk
    37
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG005
    source section id
    NCT01849783-ae
    event group key
    EG005
    event group label
    Maintenance Therapy, Year 2
    serious affected
    9
    serious at risk
    31
    other affected
    22
    other at risk
    31
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    harm key
    EG006
    source section id
    NCT01849783-ae
    event group key
    EG006
    event group label
    Long Term Follow-up
    serious affected
    1
    serious at risk
    24
    other affected
    3
    other at risk
    24
    frequency threshold
    0
    collection period
    Adverse events were collected pre-study, post-induction, pre-transplant, pre-consolidation, during maintenance therapy and long term follow-up. Up to 6 years overall.
    event definition
    Adverse events (AEs ≥ grade 3) were recorded. AEs were not recorded by start and stop date but by phase of treatment in which the AE occurred. AEs will be recorded as the worst grade achieved during that phase of treatment.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-light-chain-deposition-disease
    nct id
    NCT01849783
    qol key
    qol-0003
    source section id
    NCT01849783-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Mean Change in Quality-Of-Life Indicators Post-Transplant
    measure definition
    Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
    time frame
    Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice