Trial · NCT04273139
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy | The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Proportion of patients with VGPR to therapy within 24 cycles of therapy initiation. (VGPR is \>90% reduction in serum IgM from baseline) |
| Secondary | Number of Participants With Complete Response (CR) After 6 Cycles | 6 Cycles (28 day cycle) | Proportion of patients with a complete response after 6 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Number of Participants With Complete Response (CR) After 12 Cycles | 12 Cycles (28 day cycle) | Proportion of patients with a complete response after 12 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Number of Participants With Complete Response (CR) After 24 Cycles | Complete response to therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy. | Proportion of patients with a complete response after 24 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. |
| Secondary | Overall Response | 72 months | Proportion of patients with minor response (MR) , partial response (PR), very good partial response (VGPR), or complete response (CR) to therapy. |
| Secondary | Rate of VGPR at 30 Months | 30 Months | Proportion of patients with a VGPR at 30 months from beginning therapy. |
| Secondary | Median Time to Response | 24 months | Time from treatment initiation until achievement of a minor response (reduction in serum IgM \>25%) or better. |
| Secondary | Median Time to Major Response | 24 months | Time from treatment initiation until partial response or better (\>50% reduction in serum IgM) |
| Secondary | Progression Free Survival (PFS) at 24 Months | 24 months | Time from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase). |
| Secondary | Progression Free Survival (PFS) at 36 Months | 36 Months | Time from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase). |
| Secondary | Progression Free Survival (PFS) at 48 Months | 48 Months | Time from initiation of therapy until disease progression (\>25% increase in serum IgM and 500 mg/dL absolute increase). |
| Secondary | Time to Next Treatment | 72 months | Time from initiation of IVEN protocol therapy until initiation of new line of therapy. |
| Secondary | Number of Participants With Treatment Related Adverse Events as Assessed (CTCAE) Version 5.0 | 6 Months | CTCAE version 5.0 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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