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NCT00040846 · STUDY IN CONTEXT

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

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

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

primary · POSTED

Percentage patients with Day 100 transplant related mortality.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

→

primary · POSTED

Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

→

primary · POSTED

Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

→

secondary · POSTED

Percentage patients who experienced infections within 100 days post-transplant.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

→

secondary · POSTED

Percentage patients who relapsed/progressed within 1 year post-transplant.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

→

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-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00040846
trial label
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
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
5
harms Count
6
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    source section id
    NCT00040846-om-0000
    source outcome index
    0
    endpoint
    Evaluate the Risk of Transplant Related Mortality.
    endpoint definition
    Percentage patients with Day 100 transplant related mortality.
    time origin
    100 days after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    source section id
    NCT00040846-om-0001
    source outcome index
    1
    endpoint
    Evaluate the Risk of Occurrence of Acute and Chronic GVHD
    endpoint definition
    Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
    time origin
    1 year after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0002
    source section id
    NCT00040846-om-0002
    source outcome index
    2
    endpoint
    Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
    endpoint definition
    Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.
    time origin
    100 days after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0003
    source section id
    NCT00040846-om-0003
    source outcome index
    3
    endpoint
    Evaluate the Risk/Incidence of Infections
    endpoint definition
    Percentage patients who experienced infections within 100 days post-transplant.
    time origin
    100 days after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0004
    source section id
    NCT00040846-om-0004
    source outcome index
    4
    endpoint
    Evaluate the Risk for Disease Progression and Relapse
    endpoint definition
    Percentage patients who relapsed/progressed within 1 year post-transplant.
    time origin
    1 year after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Dose Level 1 (No Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Dose Level 2 (0.025 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Dose Level 3 (0.050 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Dose Level 4 (0.10 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Dose Level 5 (0.20 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Dose Level 6 (0.40 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dose Level 1 (No Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose Level 2 (0.025 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Dose Level 3 (0.050 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Dose Level 4 (0.10 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG004
    arm label
    Dose Level 5 (0.20 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    outcome key
    om-0001
    arm key
    OG005
    arm label
    Dose Level 6 (0.40 mg/kg/Day Campath)
    regimen
    CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00040846-om-0001#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG000
    source section id
    NCT00040846-ae
    event group key
    EG000
    event group label
    Dose Level 1 (No Campath)
    serious affected
    24
    serious at risk
    60
    other affected
    33
    other at risk
    60
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG001
    source section id
    NCT00040846-ae
    event group key
    EG001
    event group label
    Dose Level 2 (0.025 mg/kg/Day Campath)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG002
    source section id
    NCT00040846-ae
    event group key
    EG002
    event group label
    Dose Level 3 (0.050 mg/kg/Day Campath)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG003
    source section id
    NCT00040846-ae
    event group key
    EG003
    event group label
    Dose Level 4 (0.10 mg/kg/Day Campath)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG004
    source section id
    NCT00040846-ae
    event group key
    EG004
    event group label
    Dose Level 5 (0.20 mg/kg/Day Campath)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00040846
    harm key
    EG005
    source section id
    NCT00040846-ae
    event group key
    EG005
    event group label
    Dose Level 6 (0.40 mg/kg/Day Campath)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    event definition
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    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