TriangleNCT01169337 · STUDY IN CONTEXT
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering 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
Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events
PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 1-year PFS rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
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-light-chain-deposition-disease
- nct id
- NCT01169337
- trial label
- Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering 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
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0000
- source section id
- NCT01169337-om-0000
- source outcome index
- 0
- endpoint
- Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)
- endpoint definition
- Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events
- time origin
- Assessed every 4 weeks while on treatment up to 24 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The first 36 patients in the phase II part as planned in the study design
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0001
- source section id
- NCT01169337-om-0001
- source outcome index
- 1
- endpoint
- 2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)
- endpoint definition
- PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
- time origin
- Assessed every 3 months for 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0002
- source section id
- NCT01169337-om-0002
- source outcome index
- 2
- endpoint
- Proportion of Participants With Response (Phase II Secondary Endpoint)
- endpoint definition
- Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
- time origin
- Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All registered patients in the phase II part
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0003
- source section id
- NCT01169337-om-0003
- source outcome index
- 3
- endpoint
- Proportion of Participants With Response (Phase III Secondary Endpoint)
- endpoint definition
- Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
- time origin
- Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Among randomized patients who received treatment or observation
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0004
- source section id
- NCT01169337-om-0004
- source outcome index
- 4
- endpoint
- 1-year Progression-free Survival (PFS) Rate (Phase III Secondary Endpoint)
- endpoint definition
- PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 1-year PFS rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
- time origin
- Assessed every 3 months for one year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0005
- source section id
- NCT01169337-om-0005
- source outcome index
- 5
- endpoint
- 2-year Progression-free Rate (Phase III Secondary Endpoint)
- endpoint definition
- TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
- time origin
- Assessed every 3 months for 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients in the phase III part of the study
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase II)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase III)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 90
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B (Observation; Phase III)
- regimen
- Patients undergo observation until progression to symptomatic myeloma.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase II)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase III)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (Observation; Phase III)
- regimen
- Patients undergo observation until progression to symptomatic myeloma.
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase III)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 90
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B (Observation; Phase III)
- regimen
- Patients undergo observation until progression to symptomatic myeloma.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A (Lenalidomide; Phase III)
- regimen
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 90
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B (Observation; Phase III)
- regimen
- Patients undergo observation until progression to symptomatic myeloma.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01169337-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-light-chain-deposition-disease
- nct id
- NCT01169337
- harm key
- EG000
- source section id
- NCT01169337-ae
- event group key
- EG000
- event group label
- Arm A (Lenalidomide; Phase II)
- serious affected
- 23
- serious at risk
- 44
- other affected
- 14
- other at risk
- 44
- frequency threshold
- 5
- collection period
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
- event definition
- Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- harm key
- EG001
- source section id
- NCT01169337-ae
- event group key
- EG001
- event group label
- Arm A (Lenalidomide; Phase III)
- serious affected
- 40
- serious at risk
- 88
- other affected
- 20
- other at risk
- 88
- frequency threshold
- 5
- collection period
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
- event definition
- Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
- 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-light-chain-deposition-disease
- nct id
- NCT01169337
- harm key
- EG002
- source section id
- NCT01169337-ae
- event group key
- EG002
- event group label
- Arm B (Observation; Phase III)
- serious affected
- 8
- serious at risk
- 86
- other affected
- 5
- other at risk
- 86
- frequency threshold
- 5
- collection period
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
- event definition
- Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
- 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