Trial · NCT01198067
Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
NCT01198067, Phase 1, Terminated, M.D. Anderson Cancer Center; results first posted 2025-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia. Trials, record NCT01198067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01198067
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
- NCT number
- NCT01198067
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Recurrent Waldenstrom Macroglobulinemia, Refractory Waldenstrom Macroglobulinemia
- Interventions
- Pomalidomide
- First posted
- 2010-09-09
- Last updated
- 2025-09-04
- Results first posted
- 2025-09-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing MTD | Participants Experiencing Study Medication Maximum Tolerated Dose through Study Completion (Avg. 1 Year) | Maximum Tolerated Dose |
| Secondary | Cycles Completed | Study Completion (Avg. 1 Year) | Length of Treatment |
| Secondary | Changes in Waldestrom Biomarkers | Through Study Completion (Avg. 1 Year) | Average Paraprotein1 gm/dL Change Cycle 1 thru Study |
| Secondary | Changes in Waldestrom Biomarkers | Through Study Completion (Avg. 1 Year) | Average Reduction in IgM Protein mg/dL from Cycle 1 thru Study |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Experiencing MTD | Participants Experiencing Study Medication Maximum Tolerated Dose through Study Completion (Avg. 1 Year) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cycles Completed | Study Completion (Avg. 1 Year) | Number of Cycles | MEDIAN | |
| SECONDARY | Changes in Waldestrom Biomarkers | Through Study Completion (Avg. 1 Year) | Paraprotein #1 gm/dL | MEAN | |
| SECONDARY | Changes in Waldestrom Biomarkers | Through Study Completion (Avg. 1 Year) | IgM Protein mg/dL | MEAN |
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 |
|---|---|---|---|---|---|
| Number of Patients Experiencing MTD | Cohort 2 | 1 | Participants | ||
| Number of Patients Experiencing MTD | Cohort 3 | 5 | Participants | ||
| Cycles Completed | Cohort 2 | 2 | Full Range 1 to 2 | Number of Cycles | |
| Cycles Completed | Cohort 3 | 7 | Full Range 4 to 12 | Number of Cycles | |
| Changes in Waldestrom Biomarkers | Cohort 2 | 0.3 | Standard Deviation .1 | Paraprotein #1 gm/dL | |
| Changes in Waldestrom Biomarkers | Cohort 3 | 1.4 | Standard Deviation .7 | Paraprotein #1 gm/dL | |
| Changes in Waldestrom Biomarkers | Cohort 2 | 493 | Standard Deviation 955 | IgM Protein mg/dL | |
| Changes in Waldestrom Biomarkers | Cohort 3 | 1252 | Standard Deviation 2011 | IgM Protein mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 2 | 3 | |
| Overall Study | STARTED | Cohort 3 | 6 | |
| Overall Study | COMPLETED | Cohort 2 | 3 | |
| Overall Study | COMPLETED | Cohort 3 | 6 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 0 |
Source ClinicalTrials.gov
Adverse events212
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 | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 2 | 1 | 3 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 3 | 1 | 6 | 1 |
| other | Allergy/Immunology (Other) - Allergic Sinusitis | General disorders | Cohort 2 | 1 | 3 | 1 |
| other | Allergy/Immunology (Other) - Allergic Sinusitis | General disorders | Cohort 3 | 1 | 6 | 1 |
| other | Allergy/Immunology (Other) - Lidocaine | General disorders | Cohort 2 | 0 | 3 | 0 |
| other | Allergy/Immunology (Other) - Lidocaine | General disorders | Cohort 3 | 1 | 6 | 1 |
| other | Allergy/Immunology (Other) - Respiratory | Respiratory, thoracic and mediastinal disorders | Cohort 2 | 1 | 3 | 1 |
| other | Allergy/Immunology (Other) - Respiratory | Respiratory, thoracic and mediastinal disorders | Cohort 3 | 1 | 6 | 1 |
| other | Anxiety | Nervous system disorders | Cohort 2 | 2 | 3 | 2 |
| other | Anxiety | Nervous system disorders | Cohort 3 | 2 | 6 | 2 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 2 | 0 | 3 |
| Total, all-cause mortality | Cohort 3 | 0 | 6 |
| Total, other adverse events | Cohort 2 | 3 | 3 |
| Total, other adverse events | Cohort 3 | 6 | 6 |
| Total, serious adverse events | Cohort 2 | 3 | 3 |
| Total, serious adverse events | Cohort 3 | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 2 vs Cohort 3: Number of Patients Experiencing MTD | Trial comparisons |
| Cohort 2 vs Cohort 3: deaths from any cause | Trial comparisons |
| Cohort 2 vs Cohort 3: serious adverse events | Trial comparisons |
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/NCT01198067
GET https://conductscience.org/api/trials/v1/NCT01198067/events?page=2