Trial · NCT00564889
Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
NCT00564889, Phase 2, Completed, Mayo Clinic; results first posted 2011-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis. Trials, record NCT00564889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00564889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
- NCT number
- NCT00564889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- cyclophosphamide, dexamethasone, lenalidomide
- First posted
- 2007-11-29
- Last updated
- 2013-05-14
- Results first posted
- 2011-08-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) | Duration on study (up to 3 years) | Response that was confirmed on 2 consecutive evaluations during treatment. 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 \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels. |
| Secondary | Number of Patients With Organ Response | Duration of study (up to 3 years) | Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid. Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of \>= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by \>= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either \>= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to \< 50% of previous movements/day, or decrease in fecal fat excretion by 50%. |
| Secondary | Number of Participants With Severe Adverse Events | Duration of study (up to 3 years) | Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. |
| Secondary | Progression Free Survival (PFS) | Duration of study (up to 3 years) | Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. |
| Secondary | Overall Survival (OS) | Duration of study (up to 3 years) | Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) | Duration on study (up to 3 years) | participants | NUMBER | |
| SECONDARY | Number of Patients With Organ Response | Duration of study (up to 3 years) | participants | NUMBER | |
| SECONDARY | Number of Participants With Severe Adverse Events | Duration of study (up to 3 years) | participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | Duration of study (up to 3 years) | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Duration of study (up to 3 years) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) | Len/Cyc/Dex | 21 | participants | ||
| Number of Patients With Organ Response | Len/Cyc/Dex | 11 | participants | ||
| Number of Participants With Severe Adverse Events | Len/Cyc/Dex | 26 | participants | ||
| Progression Free Survival (PFS) | Len/Cyc/Dex | 28.3 | 95% Confidence Interval 12.1 to NA | months | |
| Overall Survival (OS) | Len/Cyc/Dex | 37.8 | 95% Confidence Interval 12.3 to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Len/Cyc/Dex | 35 | |
| Overall Study | COMPLETED | Len/Cyc/Dex | 6 | |
| Overall Study | NOT COMPLETED | Len/Cyc/Dex | 29 |
Source ClinicalTrials.gov
Adverse events127
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Len/Cyc/Dex | 32 | 35 | 250 |
| other | Atrial fibrillation | Cardiac disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Atrial flutter | Cardiac disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Left ventricular dysfunction | Cardiac disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Len/Cyc/Dex | 10 | 35 | 17 |
| other | Hypothyroidism | Endocrine disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Cataract | Eye disorders | Len/Cyc/Dex | 1 | 35 | 4 |
| other | Eye disorder | Eye disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Len/Cyc/Dex | 1 | 35 | 1 |
| other | Constipation | Gastrointestinal disorders | Len/Cyc/Dex | 21 | 35 | 124 |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Len/Cyc/Dex | ||
| Total, other adverse events | Len/Cyc/Dex | 35 | 35 |
| Total, serious adverse events | Len/Cyc/Dex | 24 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22504925 | RESULT |
Source PubMed
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/NCT00564889
GET https://conductscience.org/api/trials/v1/NCT00564889/events?page=2