Trial · NCT00976248
Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia
NCT00976248, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia. Trials, record NCT00976248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00976248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia
- NCT number
- NCT00976248
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom's Macroglobulinemia
- Interventions
- RAD001
- First posted
- 2009-09-14
- Last updated
- 2018-10-03
- Results first posted
- 2014-06-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate of RAD001 in Patients With Previously Untreated WM | End of Treatment, an average of 16 months | Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein. Very Good Partial Response: \> 90% reduction in serum IgM levels. Partial Response: \> 50% reduction in serum IgM levels. Minor Response: 25-49% reduction in serum IgM levels Progressive Disease: greater than 25% increase in serum IgM level occurs from the lowest attained response value or progression of clinically significant disease related symptom(s). Stable Disease: \< 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM |
| Primary | Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM. | End of Treatment, an average of 16 months | Progression is defined as a 25% increase in serum IgM from the lowest attained response value or progression of clinically significant disease related symptoms. |
| Primary | Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM | End of follow-up, an average of 18 months |
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 | Overall Response Rate of RAD001 in Patients With Previously Untreated WM | End of Treatment, an average of 16 months | participants | NUMBER | |
| PRIMARY | Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM. | End of Treatment, an average of 16 months | 13 participants were excluded from this analysis due to treatment and follow-up ending prior to progression. | Months | MEDIAN |
| PRIMARY | Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM | End of follow-up, an average of 18 months | 13 participants were censored due to follow-up ending prior to new therapy initiation. | Months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Overall Response Rate of RAD001 in Patients With Previously Untreated WM | RAD001 | 22 | participants | ||
| Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM. | RAD001 | 21 | Full Range 1 to 64 | Months | |
| Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM | RAD001 | 15 | Full Range 1 to 69 | 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 | RAD001 | 33 | |
| Overall Study | COMPLETED | RAD001 | 33 | |
| Overall Study | NOT COMPLETED | RAD001 | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Anemia | Blood and lymphatic system disorders | RAD001 | 8 | 33 | 8 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | RAD001 | 5 | 33 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | RAD001 | 5 | 33 | 5 |
| other | Hyperglycemia | Metabolism and nutrition disorders | RAD001 | 2 | 33 | 2 |
| other | Oral ulcerations | Gastrointestinal disorders | RAD001 | 7 | 33 | 7 |
| other | Pneumonitis | Respiratory, thoracic and mediastinal disorders | RAD001 | 5 | 33 | 5 |
| other | Fatigue | General disorders | RAD001 | 4 | 33 | 4 |
| other | Rash | Skin and subcutaneous tissue disorders | RAD001 | 2 | 33 | 2 |
| other | Cellulitis | Infections and infestations | RAD001 | 2 | 33 | 2 |
| serious | Pain | Musculoskeletal and connective tissue disorders | RAD001 | 1 | 33 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RAD001 | ||
| Total, other adverse events | RAD001 | 33 | 33 |
| Total, serious adverse events | RAD001 | 7 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27836860 | 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/NCT00976248
GET https://conductscience.org/api/trials/v1/NCT00976248/registered