Trial · NCT02400437
Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia
NCT02400437, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2020-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia. Trials, record NCT02400437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02400437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia
- NCT number
- NCT02400437
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Waldenstrom's Macroglobulinemia
- Interventions
- Ixazomib, Dexamethasone, Rituximab
- First posted
- 2015-03-27
- Last updated
- 2020-09-02
- Results first posted
- 2020-09-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Very Good Partial Response Rate (VGPR) for IDR | 76 weeks | Rate of very good partial response or better in patients treated with IDR. VGPR is defined as a \>90% reduction in serum IgM levels from baseline. |
| Secondary | Overall Response Rate | 2 Years | Overall response includes the rate of complete response (CR), partial response (PR), minimal response (MR), stabl disease (SD) and progressive disease (PD). Minor response is \>25%-50% reduction in serum IgM from baseline. Partial Response is (\>50-90% reduction in serum IgM from baseline. Very Good Partial Response is \>90% reduction in serum IgM from baseline. Complete Response is resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly. |
| Secondary | Progression-free Survival (PFS) | From start of treatment to time of disease progression, assessed up to 4 years after treatment start | Duration of time from start of treatment to disease progression. Progressive disease is defined as occurring when a \>25% increase in serum IgM and an absolute 500mg/dL increase in IgM level occurs from the lowest attained response value, or progression of clinically significant disease related symptoms. |
| Secondary | Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status | 2 Years | To evaluate the overall response rate of participants by MYD88 L265P and CXCR4-WHIM mutations in WM. Overall response is defined as achieving at least a minor response, or \>25% reduction in serum IgM from baseline. |
| Secondary | Time to Progression (TTP) | From start of treatment to time of disease progression, assessed up to 4 years after treatment start | Duration of time from start of treatment to time of disease progression. |
| Secondary | Duration of Response (DOR) | From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment start | The duration of response is measured from the time a participant achieved a response until the date of progression. |
| Secondary | Time to Next Therapy (TTNT) | From start of treatment until the participant begins a new therapy, assessed up to 4 years after treatment start | Duration from start of protocol treatment to time of initiation of new therapy. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Very Good Partial Response Rate (VGPR) for IDR | 76 weeks | All participants who have received at least 1 cycle of therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate | 2 Years | All participants who received at least 1 cycle of therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | From start of treatment to time of disease progression, assessed up to 4 years after treatment start | All participants who received at least 1 cycle of therapy. Participants were followed for up to 2 years after treatment discontinuation. | months | MEDIAN |
| SECONDARY | Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status | 2 Years | Number of participants who achieved a response by mutational status | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression (TTP) | From start of treatment to time of disease progression, assessed up to 4 years after treatment start | All participants who received 1 cycle of treatment. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the time each participant achieved a response to time of disease progression, assessed up to 4 years after treatment start | All participants who achieved a response to therapy. | months | MEDIAN |
| SECONDARY | Time to Next Therapy (TTNT) | From start of treatment until the participant begins a new therapy, assessed up to 4 years after treatment start | 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 |
|---|---|---|---|---|---|
| Very Good Partial Response Rate (VGPR) for IDR | Ixazomib, Dexamethasone, Rituximab | 5 | Participants | ||
| Overall Response Rate | Ixazomib, Dexamethasone, Rituximab | 25 | Participants | ||
| Progression-free Survival (PFS) | Ixazomib, Dexamethasone, Rituximab | 33 | Full Range 4 to 46 | months | |
| Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status | MYD88 Mutated, CXCR4 Wild-type | 11 | Participants | ||
| Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status | MYD88 Mutated, CXCR4 Mutated | 14 | Participants | ||
| Time to Progression (TTP) | Ixazomib, Dexamethasone, Rituximab | 33 | Full Range 4 to 46 | months | |
| Duration of Response (DOR) | Ixazomib, Dexamethasone, Rituximab | 33 | Full Range 2 to 41 | months | |
| Time to Next Therapy (TTNT) | Ixazomib, Dexamethasone, Rituximab | 39 | Full Range 4 to 46 | 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 | Ixazomib, Dexamethasone, Rituximab | 26 | |
| Overall Study | COMPLETED | Ixazomib, Dexamethasone, Rituximab | 26 | |
| Overall Study | NOT COMPLETED | Ixazomib, Dexamethasone, Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events95
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 | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Palpitations | Cardiac disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Ixazomib, Dexamethasone, Rituximab | 2 | 26 | 2 |
| other | Ventricular arrhythmia | Cardiac disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Hearing loss | Ear and labyrinth disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Ixazomib, Dexamethasone, Rituximab | 2 | 26 | 2 |
| other | Blurry vision | Eye disorders | Ixazomib, Dexamethasone, Rituximab | 3 | 26 | 3 |
| other | Cataract | Eye disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
| other | Conjunctivitis | Eye disorders | Ixazomib, Dexamethasone, Rituximab | 1 | 26 | 1 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixazomib, Dexamethasone, Rituximab | 0 | 26 |
| Total, other adverse events | Ixazomib, Dexamethasone, Rituximab | 25 | 26 |
| Total, serious adverse events | Ixazomib, Dexamethasone, Rituximab | 4 | 26 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MYD88 Mutated, CXCR4 Wild-type vs MYD88 Mutated, CXCR4 Mutated: Overall Response Rate by MYD88 L265P and CXCR4-WHIM Status |
Source 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/NCT02400437
GET https://conductscience.org/api/trials/v1/NCT02400437/events?page=2