Trial · NCT04131309
A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis
NCT04131309, Phase 2, Completed, Stichting European Myeloma Network
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis. Trials, record NCT04131309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04131309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis
- NCT number
- NCT04131309
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Stichting European Myeloma Network
- Conditions
- Light Chain (AL) Amyloidosis, Stage 3B
- Interventions
- Daratumumab, Bortezomib Injection, Dexamethasone oral tablet
- First posted
- 2019-10-18
- Last updated
- 2026-11-12
- Other registries' IDs
- eudract:2018-004333-33
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 6 months | percentage of participants |
| Secondary | Overall Response Rate (ORR) | Overall (up to 9 months), 3 and 6 months | Best hematologic response rates, per International Amyloidosis Consensus Criteria: CR Normalization of free light chain ratio, negative serum and urine immunofixation; VGPR with baseline dFLC ≥ 50 mg/L, reduction in the dFLC to \<40 mg/L; PR b. baseline dFLC ≥ 50 mg/L, reduction in dFLC by ≥ 50% c. A greater than 50% reduction in M protein concentration, baseline dFLC is \<50 mg/L, M protein (≥5 g/L) d. baseline dFLC ≥ 20 and \< 50 mg/dL: dFLC \< 10 mg/dL; No response, Less than a PR; |
| Secondary | Major Organ Deterioration Progression-Free Survival (MOD-PFS). | Overall up to death or major organ deterioration | Major Organ Deterioration Progression-Free Survival (MOD-PFS) is a composite endpoint of clinically observable endpoints and will be defined from the start of study treatment (Cycle 1 Day 1) to any one of the following events (whichever occurs first) • Death or Major organ deterioration |
| Secondary | Progression Free Survival | Overall up to 2 years | documentation of hematologic disease progression, or organ (cardiac, renal, or liver) progression/need for transplant, or need for additional therapy (excluding the addition of bortezomib under protocol) or death due to any cause, whichever occurs first according to central laboratory results and judged by international consensus guidelines |
| Secondary | Time to Hematologic Response | overall up to 2 years | to evaluate the time to hematologic response |
| Secondary | Proportion of Additional Treatment | every 28 days, from start of study treatment (cycle 1 Day1) until end of treatment with a maximum of 2 years, average of 6 months | The proportion of subjects who received additional treatment with bortezomib and low dose dexamethasone (at the investigator's discretion). |
| Secondary | Organ Response Rate (OrRR) Heart | at 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (maximum of 2 years) | the organ response rate for the heart |
| Secondary | EORTC QLQ-C30 Scores Will be Summarized at Each Time Point. | Score changes from baseline to 4 months | The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology. |
| Secondary | Organ Response Rate (OrRR) Kidney | from registration to the date of disease progression or death with a maximum of 2 years | the organ response rate for kidney involvement |
| Secondary | Organ Response Rate (OrRR) Liver | from registration to the date of disease progression or death with a maximum of 2 years | the organ response rate for liver involvement |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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 |
|---|---|
| 42296025 | DERIVED |
Source PubMed
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.
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/NCT04131309
GET https://conductscience.org/api/trials/v1/NCT04131309/registered