Trial · NCT00492050

Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia

NCT00492050, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2022-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia. Trials, record NCT00492050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00492050

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
NCT number: NCT00492050
Status: Active not recruiting
Phases: Phase 2
Enrollment: 46 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Waldenstrom's Macroglobulinemia
Interventions: Bortezomib, Rituximab, Valacyclovir
First posted: 2007-06-27
Last updated: 2026-03-11
Results first posted: 2022-05-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	After 2 (35 day) cycles of treatment	Partial response (PR) defined as at least \> 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, \> 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease. Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomegaly (confirmed by computed tomography \[CT\] scan), and no signs or symptoms attributable to WM. Stable disease defined as neither grown nor shrunk; the amount of disease has not changed.Participants will be followed for \< 6 months after receiving bortezomib/rituximab or rituximab-modified hyper-CVAD to be considered unresponsive to therapy in accordance with the guidelines of the Consensus Panel of the Third International Workshop on Waldenstrom's Macroglobulinemia.
Primary	Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab	After 3 (35 day) cycles of treatment	Partial response (PR) defined as at least \> 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, \> 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease. Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomegaly (confirmed by computed tomography \[CT\] scan), and no signs or symptoms attributable to WM. Stable disease defined as neither grown nor shrunk; the amount of disease has not changed. Participants will be followed for \< 6 months after receiving bortezomib/rituximab or rituximab-modified hyper-CVAD to be considered unresponsive to therapy in accordance with the guidelines of the Consensus Panel of the Third International Workshop on Waldenstrom's Macroglobulinemia.
Primary	Participants Ability to Collect Stem Cells After Treatment With Bortezomib and Rituximab	4 weeks	Number of Participants who were able to collect stem cells successfully or unable to collect after treatment with bortezomib and rituximab.

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	Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	After 2 (35 day) cycles of treatment	1 subject didn't complete 2 cycles of therapy and isn't evaluable for response	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab	After 3 (35 day) cycles of treatment		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Participants Ability to Collect Stem Cells After Treatment With Bortezomib and Rituximab	4 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	All Participants	Stable Disease	20	Participants
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	All Participants	Partial Response	11	Participants
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	All Participants	Progressive Disease	2	Participants
Response Rate After 2 Cycles of Treatment With Bortezomib and Rituximab	All Participants	No Response	3	Participants
Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab	All Participants	Stable Disease	7	Participants
Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab	All Participants	Partial Response	16	Participants
Response Rate After 3 Cycles of Treatment With Bortezomib and Rituximab	All Participants	No Response	2	Participants
Participants Ability to Collect Stem Cells After Treatment With Bortezomib and Rituximab	All Participants	Participants Collected Successfully	30	Participants
Participants Ability to Collect Stem Cells After Treatment With Bortezomib and Rituximab	All Participants	Participants Unable to Collect	7	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bortezomib + Rituximab	37
Overall Study	Inadequate Response to First Two Cycles	Bortezomib + Rituximab	25
Overall Study	Inadequate Response to First 3 Cycles	Bortezomib + Rituximab	12
Overall Study	If Adequate Response to First Two Cycles-participants Proceed to Stem Cell Collection	Bortezomib + Rituximab	30
Overall Study	COMPLETED	Bortezomib + Rituximab	28
Overall Study	NOT COMPLETED	Bortezomib + Rituximab	9

Source ClinicalTrials.gov

Adverse events33

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
other	Fatigue	General disorders	All Participants	6	37
other	Diarrhea	Gastrointestinal disorders	All Participants	3	37
other	Pain (joint)	Musculoskeletal and connective tissue disorders	All Participants	4	37
other	Pain (muscle)	Musculoskeletal and connective tissue disorders	All Participants	4	37
other	Neutropenia	Blood and lymphatic system disorders	All Participants	4	37
other	Dizziness	Nervous system disorders	All Participants	2	37
other	Vomiting	Gastrointestinal disorders	All Participants	2	37
other	BUN increase	Renal and urinary disorders	All Participants	1	37
other	Creatinine increase	Renal and urinary disorders	All Participants	1	37
other	Dry eye	Eye disorders	All Participants	3	37

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Participants	0	37
Total, other adverse events	All Participants	14	37
Total, serious adverse events	All Participants	14	37

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00492050

GET https://conductscience.org/api/trials/v1/NCT00492050/events?page=2

API reference For AI assistants