Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma

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

Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.

Per protocol, patients who completed the day 80-120 evaluation assessments.

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secondary · POSTED

Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Patients who were treated per protocol.

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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-darzalex-faspro-f9050675
nct id: NCT00217438
trial label: Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0000
source section id
NCT00217438-om-0000
source outcome index
0
endpoint
CR and Near CR Rates
endpoint definition
Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.
time origin
Up to 120 days after transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Per protocol, patients who completed the day 80-120 evaluation assessments.
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-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0001
source section id
NCT00217438-om-0001
source outcome index
1
endpoint
Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2
endpoint definition
Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
time origin
Up to day 56 after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were treated per protocol.
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-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0000
arm key
OG000
arm label
Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
regimen
INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00217438-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0000
arm key
OG001
arm label
Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
regimen
INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00217438-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0001
arm key
OG000
arm label
Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
regimen
INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
analyzed count
66
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00217438-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
outcome key
om-0001
arm key
OG001
arm label
Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
regimen
INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00217438-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
harm key
EG000
source section id
NCT00217438-ae
event group key
EG000
event group label
Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
serious affected
0
serious at risk
66
other affected
14
other at risk
66
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
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00217438
harm key
EG001
source section id
NCT00217438-ae
event group key
EG001
event group label
Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
serious affected
0
serious at risk
64
other affected
7
other at risk
64
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