Trial · NCT01572480
Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
NCT01572480, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma. Trials, record NCT01572480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01572480
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
- NCT number
- NCT01572480
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib, Revlimid, Dexamethasone
- First posted
- 2012-04-06
- Last updated
- 2026-03-10
- Results first posted
- 2022-09-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria | 8 months | MRDnegative Complete Response (CR) per the IMWHG criteria is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher. |
| Secondary | Percentage of Participants That Have Minimal Residual Disease (MRD)-Negative Complete Response (CR) for a Minimum of 1 Year | 1 year | Percentage of participants that have Minimal Residual Disease (MRD)-negative Complete Response (CR) for a minimum of 1 year estimated along with a 95% two-sided confidence interval. MRDnegative Complete Response (CR) is defined as absence of phenotypically aberrant clonal plasma cells by flow cytometry on bone marrow aspirates using the eight-color two tube approach with a minimum sensitivity of 1 in 10\^5 nucleated cells or higher. |
| Secondary | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 117 months and 1 day. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | Clinical Progression Free Survival | time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, up to 5 years | Clinical progression was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder. |
| Secondary | Biochemical Progression Free Survival | time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by IMWG criteria, up to 5 years | Biochemical progression free survival is defined as the time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by International Myeloma Working Group (IMWG) criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. |
| Secondary | Duration of Response | through study completion, for a maximum of 12 years and 7 days | Duration of response is defined as the time from partial response to disease progression. Response was assessed by the International Myeloma Working Group Criteria for Multiple Myeloma. Partial Response is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. |
| Secondary | Overall Response Rate | time measurement criteria are met for best response until the first date that recurrent or progressive disease is met, up to 5 years | Overall response is defined as the percentage of participants who have a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) defined by the International Myeloma Working Group Criteria for Multiple Myeloma out of all evaluable participants. PR is ≥50% reduction if serum M-protein and reduction in 24-hour(h) urinary M-protein by ≥90% or to \<200mg per 24h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis. CR is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≥5% plasma cells in bone marrow. sCR is complete response plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria | 8 months | 54/55 participants are evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants That Have Minimal Residual Disease (MRD)-Negative Complete Response (CR) for a Minimum of 1 Year | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 117 months and 1 day. | 54/55 participants are evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Progression Free Survival | time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, up to 5 years | 54/55 participants are evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Biochemical Progression Free Survival | time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by IMWG criteria, up to 5 years | 54/55 participants are evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | through study completion, for a maximum of 12 years and 7 days | years | MEDIAN | |
| SECONDARY | Overall Response Rate | time measurement criteria are met for best response until the first date that recurrent or progressive disease is met, up to 5 years | 54/55 participants are evaluable for this outcome measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria | All Participants | 70.4 | 95% Confidence Interval 56.4 to 82.0 | percentage of participants | |
| Percentage of Participants That Have Minimal Residual Disease (MRD)-Negative Complete Response (CR) for a Minimum of 1 Year | All Participants | 63 | 95% Confidence Interval 49.0 to 76.0 | percentage of participants | |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | All Participants | 54 | Participants | ||
| Clinical Progression Free Survival | All Participants | 90.7 | 95% Confidence Interval 71.0 to 97.2 | percentage of participants | |
| Biochemical Progression Free Survival | All Participants | 76.6 | 95% Confidence Interval 59.2 to 87.3 | percentage of participants | |
| Duration of Response | All Participants | 7.9 | 95% Confidence Interval 6.7 to NA | years | |
| Overall Response Rate | All Participants | Overall Response Rate | 100 | percentage of participants | |
| Overall Response Rate | All Participants | Partial Response | 5.5 | percentage of participants | |
| Overall Response Rate | All Participants | Very Good Partial Response | 18.5 | percentage of participants | |
| Overall Response Rate | All Participants | Complete Response | 0 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Participants Enrolled | STARTED | All Participants | 55 | |
| Participants Enrolled | COMPLETED | All Participants | 54 | |
| Participants Enrolled | NOT COMPLETED | All Participants | 1 | |
| Drug Administration | STARTED | All Participants | 54 | |
| Drug Administration | COMPLETED | All Participants | 53 | |
| Drug Administration | NOT COMPLETED | All Participants | 1 | |
| Initiated Maintenance Therapy | STARTED | All Participants | 53 | |
| Initiated Maintenance Therapy | COMPLETED | All Participants | 50 | |
| Initiated Maintenance Therapy | NOT COMPLETED | All Participants | 3 | |
| Completed Maintenance Therapy | STARTED | All Participants | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events169
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | All Participants | 4 | 54 | 5 |
| other | Activated partial thromboplastin time prolonged | Investigations | All Participants | 3 | 54 | 7 |
| other | Agitation | Psychiatric disorders | All Participants | 1 | 54 | 1 |
| other | Alanine aminotransferase increased | Investigations | All Participants | 14 | 54 | 46 |
| other | Alkaline phosphatase increased | Investigations | All Participants | 15 | 54 | 27 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | All Participants | 2 | 54 | 2 |
| other | Anaphylaxis | Immune system disorders | All Participants | 1 | 54 | 1 |
| other | Anemia | Blood and lymphatic system disorders | All Participants | 16 | 54 | 59 |
| other | Anorexia | Metabolism and nutrition disorders | All Participants | 4 | 54 | 4 |
| other | Anxiety | Psychiatric disorders | All Participants | 2 | 54 | 2 |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 54 |
| Total, other adverse events | All Participants | 54 | 54 |
| Total, serious adverse events | All Participants | 12 | 54 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01572480
GET https://conductscience.org/api/trials/v1/NCT01572480/events?page=2