Trial · NCT04009109
Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
NCT04009109, Phase 2, Active not recruiting, Alliance Foundation Trials, LLC.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM. Trials, record NCT04009109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04009109
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
- NCT number
- NCT04009109
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Conditions
- Myeloma, Multiple
- Interventions
- Lenalidomide, Ixazomib, Daratumumab Injection, Dexamethasone
- First posted
- 2019-07-05
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Impact of Study Treatment on Progression Free Survival (PFS) | 5 Years | Time interval between registration and progression or death. |
| Secondary | Minimal Residual Disease (MRD) | 5 Years | Minimal residual disease (MRD) negativity in the blood and marrow will be determined using the IMWG criteria. |
| Secondary | Toxicity Profile of Treatment Arm Based on Patient Response | 5 Years | Evaluation of incidence and severity of adverse events by summaries of toxicity data/contingency tables. |
| Secondary | Overall Response Rate (ORR) | 5 Years | Proportion of patients with reduction in tumor burden of a predefined amount. |
| Secondary | Overall Survival (OS) | 5 Years | Time from registration to death due to any cause. |
| Secondary | Quality of Life with the EQ 5D 5L Questionnaire | 5 Years | Consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
| Secondary | Quality of Life with the EORTC QLQ-MY20 Questionnaire | 5 Years | The EORTC QLQ-MY20 module was developed as an addition to the QLQ-C30 for use specifically in MM. It has 4 domains (disease symptoms, side effects of treatment, body image, future perspectives). Scores range from 0 to 100; good HRQoL is indicated by high scores for future perspective and body image, and low scores for disease symptoms and side effects of treatment. |
| Secondary | Quality of Life with the EORTC QLQ-C30 Questionnaire | 5 Years | The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Rate of Adherence to Lenalidomide and Ixazomib | 5 Years | All patients who have begun treatment will be included in the estimate of adherence rate to lenalidomide and the estimate of the adherence rate to ixazomib. |
| Secondary | Alliance Geriatric Assessment with IMWG Fragility Score | 5 Years | To describe functional status, comorbidity, psychological state, social activity, social support, chemotherapy toxicity, and nutrition using the geriatric assessment tool. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers24
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 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/NCT04009109
GET https://conductscience.org/api/trials/v1/NCT04009109/papers?page=2