Trial · NCT00142116
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
NCT00142116, Phase 2, Completed, Steven P. Treon, MD, PhD; results first posted 2014-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia. Trials, record NCT00142116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00142116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
- NCT number
- NCT00142116
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Steven P. Treon, MD, PhD
- Conditions
- Waldenstrom's Macroglobulinemia, Lymphoplasmacytic Lymphoma
- Interventions
- Thalidomide, Rituximab
- First posted
- 2005-09-02
- Last updated
- 2014-06-02
- Results first posted
- 2014-06-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 3 years | Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 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. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s). |
| Primary | Time to Progression | 49.1 months | Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method. |
| Secondary | To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity. | 3 years |
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 | Objective Response Rate | 3 years | Intent-to-treat basis | participants | NUMBER |
| SECONDARY | To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity. | 3 years | |||
| PRIMARY | Time to Progression | 49.1 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | All WM Patients | Complete Response | 1 | participants | |
| Objective Response Rate | All WM Patients | Partial Response | 15 | participants | |
| Objective Response Rate | All WM Patients | Minor Response | 2 | participants | |
| Objective Response Rate | All WM Patients | Stable Disease | 7 | participants | |
| Time to Progression | Thalidomide and Rituximab | TTP for all evaluable patients | 34.8 | Full Range 1.0 to 49.1 | months |
| Time to Progression | Thalidomide and Rituximab | TTP for responding patients | 38.7 | Full Range 10.3 to 49.1 | months |
| Time to Progression | Thalidomide and Rituximab | TTP for previously treated patients | 15.25 | Full Range 1.0 to 45.8 | months |
| Time to Progression | Thalidomide and Rituximab | TTP for previously untreated patients | 36.04 | Full Range 2.5 to 49.1 | 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 | All WM Patients | 25 | |
| Overall Study | COMPLETED | All WM Patients | 25 | |
| Overall Study | NOT COMPLETED | All WM Patients | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Peripheral Neuropathy | Nervous system disorders | All WM Patients | 11 | 25 | 11 |
| other | Somnolence | Nervous system disorders | All WM Patients | 3 | 25 | 3 |
| other | Confusion | Nervous system disorders | All WM Patients | 3 | 25 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | All WM Patients | 2 | 25 | 2 |
| other | Tremors | Nervous system disorders | All WM Patients | 2 | 25 | 2 |
| other | Bradycardia | Cardiac disorders | All WM Patients | 2 | 25 | 2 |
| serious | Death | Respiratory, thoracic and mediastinal disorders | All WM Patients | 1 | 25 | 1 |
| serious | Death | Cardiac disorders | All WM Patients | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All WM Patients | ||
| Total, other adverse events | All WM Patients | 19 | 25 |
| Total, serious adverse events | All WM Patients | 2 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18713945 | RESULT |
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/NCT00142116
GET https://conductscience.org/api/trials/v1/NCT00142116/registered