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← Plasma Cell Neoplasms

NCT01350245 · STUDY IN CONTEXT

Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

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

1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.

Source null

→

primary · POSTED

Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.

Source null

→

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

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-plasma-cell-neoplasms
nct id
NCT01350245
trial label
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
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
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT01350245
    outcome key
    om-0000
    source section id
    NCT01350245-om-0000
    source outcome index
    0
    endpoint
    Disease-Free Survival (DFS)
    endpoint definition
    1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.
    time origin
    1 year post-transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-plasma-cell-neoplasms
    nct id
    NCT01350245
    outcome key
    om-0001
    source section id
    NCT01350245-om-0001
    source outcome index
    1
    endpoint
    Probability of Overall Survival at 15 Months Post-treatment
    endpoint definition
    Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.
    time origin
    15 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-plasma-cell-neoplasms
    nct id
    NCT01350245
    outcome key
    om-0000
    arm key
    OG000
    arm label
    TJU 2 Step Regimen
    regimen
    All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone. Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy). Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days. Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD) Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD) Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01350245-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT01350245
    outcome key
    om-0001
    arm key
    OG000
    arm label
    TJU 2 Step Regimen
    regimen
    All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone. Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy). Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days. Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD) Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD) Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01350245-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT01350245
    harm key
    EG000
    source section id
    NCT01350245-ae
    event group key
    EG000
    event group label
    TJU 2 Step Regimen
    serious affected
    19
    serious at risk
    28
    other affected
    28
    other at risk
    28
    frequency threshold
    0
    collection period
    Source null
    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