Trial · NCT00679367
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
NCT00679367, Phase 2, Completed, Boston Medical Center; results first posted 2017-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis. Trials, record NCT00679367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00679367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
- NCT number
- NCT00679367
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Multiple Myeloma
- Interventions
- dexamethasone, lenalidomide, melphalan
- First posted
- 2008-05-16
- Last updated
- 2017-02-20
- Results first posted
- 2017-02-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hematologic Response | one year | Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more. |
| Secondary | Number of Organs Improved or Stable Based on Description Below: | one year | Renal response - \> 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness \> 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy. |
| Secondary | Number of Participants Removed From Study Due to Toxicities | One year | Number of study participants removed from study treatment due to toxicities |
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 | Number of Participants With Hematologic Response | one year | Participants who completed at least 3 cycles of treatment | participants | NUMBER |
| SECONDARY | Number of Organs Improved or Stable Based on Description Below: | one year | number of organs stable or improved | NUMBER | |
| SECONDARY | Number of Participants Removed From Study Due to Toxicities | One year | All patients who have had at least one dose of drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hematologic Response | Melphalan Revlimid and Dexamethasone | 7 | participants | ||
| Number of Organs Improved or Stable Based on Description Below: | Melphalan Revlimid and Dexamethasone | 10 | number of organs stable or improved | ||
| Number of Participants Removed From Study Due to Toxicities | Melphalan Revlimid and Dexamethasone | 6 | Participants |
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 | Melphalan Revlimid and Dexamethasone | 16 | |
| Overall Study | COMPLETED | Melphalan Revlimid and Dexamethasone | 4 | |
| Overall Study | NOT COMPLETED | Melphalan Revlimid and Dexamethasone | 12 |
Source ClinicalTrials.gov
Adverse events120
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 bloating | Gastrointestinal disorders | Melphalan Revlimid and Dexamethasone | 2 | 16 | 2 |
| other | abdominal cramping | Gastrointestinal disorders | Melphalan Revlimid and Dexamethasone | 2 | 16 | 2 |
| other | altered taste | Gastrointestinal disorders | Melphalan Revlimid and Dexamethasone | 3 | 16 | 3 |
| other | anemia | Blood and lymphatic system disorders | Melphalan Revlimid and Dexamethasone | 11 | 16 | 24 |
| other | anorexia | Gastrointestinal disorders | Melphalan Revlimid and Dexamethasone | 4 | 16 | 4 |
| other | anxiety | Psychiatric disorders | Melphalan Revlimid and Dexamethasone | 3 | 16 | 3 |
| other | arthritis | Musculoskeletal and connective tissue disorders | Melphalan Revlimid and Dexamethasone | 2 | 16 | 2 |
| other | aspiration | Gastrointestinal disorders | Melphalan Revlimid and Dexamethasone | 1 | 16 | 1 |
| other | atrial fibrillation | Cardiac disorders | Melphalan Revlimid and Dexamethasone | 1 | 16 | 1 |
| other | blurring | Eye disorders | Melphalan Revlimid and Dexamethasone | 4 | 16 | 4 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melphalan Revlimid and Dexamethasone | ||
| Total, other adverse events | Melphalan Revlimid and Dexamethasone | 16 | 16 |
| Total, serious adverse events | Melphalan Revlimid and Dexamethasone | 16 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23144200 | DERIVED |
Source PubMed
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/NCT00679367
GET https://conductscience.org/api/trials/v1/NCT00679367/events?page=2