Trial · NCT00558896
CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
NCT00558896, Phase 2, Completed, Mayo Clinic; results first posted 2014-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis. Trials, record NCT00558896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00558896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
- NCT number
- NCT00558896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- dexamethasone, pomalidomide
- First posted
- 2007-11-15
- Last updated
- 2018-04-18
- Results first posted
- 2014-06-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Duration of study (up to 3 years) | Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels. |
| Secondary | Progression Free Survival (PFS) | Duration of study (up to 5 years) | PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method. Progression was defined as any one or more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25% increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas |
| Secondary | Duration of Response | Duration of study (up to 5 years) | Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Duration of study (up to 3 years) | participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Duration of study (up to 5 years) | months | MEDIAN | |
| SECONDARY | Duration of Response | Duration of study (up to 5 years) | Participants who achieved a partial response(PR) or better were evaluable for this analysis. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 39 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Lenalidomide Refractory Myeloma: Low Dose | 11 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 9 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose | 10 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Relapsed Myeloma (< 4 Prior Regimens): High Dose | 23 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Relapsed/Refractory Myeloma: High Dose | 25 | participants | ||
| The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) | Relapsed Amyloidosis: Low Dose | 16 | participants | ||
| Progression Free Survival (PFS) | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 13 | 95% Confidence Interval 8.1 to 20.4 | months | |
| Progression Free Survival (PFS) | Lenalidomide Refractory Myeloma: Low Dose | 5 | 95% Confidence Interval 2.7 to 10.3 | months | |
| Progression Free Survival (PFS) | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 6.4 | 95% Confidence Interval 3.2 to 8.0 | months |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 60 | |
| Overall Study | STARTED | Lenalidomide Refractory Myeloma: Low Dose | 34 | |
| Overall Study | STARTED | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 35 | |
| Overall Study | STARTED | Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose | 35 | |
| Overall Study | STARTED | Relapsed Myeloma (< 4 Prior Regimens): High Dose | 60 | |
| Overall Study | STARTED | Relapsed/Refractory Myeloma: High Dose | 120 | |
| Overall Study | STARTED | Relapsed Amyloidosis: Low Dose | 33 | |
| Overall Study | COMPLETED | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 39 | |
| Overall Study | COMPLETED | Lenalidomide Refractory Myeloma: Low Dose | 27 | |
| Overall Study | COMPLETED | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 30 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,666
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 | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 0 | 60 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Lenalidomide Refractory Myeloma: Low Dose | 0 | 34 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 0 | 35 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose | 2 | 35 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed Myeloma (< 4 Prior Regimens): High Dose | 0 | 60 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed/Refractory Myeloma: High Dose | 0 | 119 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Relapsed Amyloidosis: Low Dose | 1 | 33 | 2 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 57 | 60 | 707 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Lenalidomide Refractory Myeloma: Low Dose | 34 | 34 | 241 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 34 | 35 | 239 |
1 to 10 of 1,666Source ClinicalTrials.gov
See all 1,666 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relapsed Myeloma (<4 Prior Regimens): Low Dose | ||
| Total, all-cause mortality | Lenalidomide Refractory Myeloma: Low Dose | ||
| Total, all-cause mortality | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | ||
| Total, all-cause mortality | Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose | ||
| Total, all-cause mortality | Relapsed Myeloma (< 4 Prior Regimens): High Dose | ||
| Total, all-cause mortality | Relapsed/Refractory Myeloma: High Dose | ||
| Total, all-cause mortality | Relapsed Amyloidosis: Low Dose | ||
| Total, other adverse events | Relapsed Myeloma (<4 Prior Regimens): Low Dose | 60 | 60 |
| Total, other adverse events | Lenalidomide Refractory Myeloma: Low Dose | 34 | 34 |
| Total, other adverse events | Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose | 34 | 35 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00558896
GET https://conductscience.org/api/trials/v1/NCT00558896/results?page=2