Trial · NCT04847453
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
NCT04847453, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis. Trials, record NCT04847453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04847453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
- NCT number
- NCT04847453
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent AL Amyloidosis, Refractory AL Amyloidosis
- Interventions
Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Computed Tomography, Dexamethasone, Echocardiography Test, Ixazomib Citrate, Magnetic Resonance Imaging, Positron Emission Tomography, Transabdominal Ultrasound, Venetoclax, X-Ray Imaging
- First posted
- 2021-04-19
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events | Up to 30 days | Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Primary | Maximum tolerated dose | Up to the end of cycle 1 | Defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. |
| Primary | Recommended phase 2 dose (RP2D) | Up to the end of cycle 1 | Will be based on the assessment of toxicities during cycle 1 that meet criteria for dose-limiting toxicities (DLT). |
| Secondary | Overall response rate (complete hematologic response) | After cycles 3, 6, 9, and 12, and every 6 months thereafter up to 2.5 years | Will be estimated based on the patients enrolled in the dose-escalation as well as the dose-expansion stage, using Clopper-Pearson confidence interval. Hematologic complete response rate will be evaluated according to the consensus guidelines in treatment response. |
| Other | Expression of BCL-2, BCL-XL, BAX, BAK, BIM, NOXA, and MCL-1 | Baseline | Will be assessed by immunohistochemistry. |
| Other | Immune profile in the peripheral blood | Before and during treatment | Will be determined by mass cytometry. |
| Other | Hematologic response rates | Up to 2.5 years | Estimated using mass spectrometry to detect persistence of a monoclonal protein in the serum and urine. |
| Other | Characterization of CD138+ plasma cell with t(11;14) | Up to 2.5 years | |
| Other | Presence of minimal residual disease | Up to 2.5 years | Will be determined by Next Generation Sequencing in patients achieving a hematologic complete response. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40226119 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| UM1CA186717 | Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN | DANILOV, ALEXEY V.; COLEVAS, A. DIMITRIOS; LARA, PRIMO N.; LENZ, HEINZ JOSEF | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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/NCT04847453
GET https://conductscience.org/api/trials/v1/NCT04847453/registered