Trial · NCT04065789
Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients
NCT04065789, Phase 2, Completed, Tel-Aviv Sourasky Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients. Trials, record NCT04065789. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04065789
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients
- NCT number
- NCT04065789
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Conditions
- Myeloma Multiple, Myeloma, Plasma-Cell, Myeloma-Multiple, Plasma Cell Myeloma
- Interventions
- Carfilzomib, Daratumumab, Lenalidomide, Dexamethasone
- First posted
- 2019-08-22
- Last updated
- 2022-01-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients who experience any AE incidence, grade > 2 drug-elicited toxicities, peripheral neuropathy events (Grade 2 or higher). | from screening through month 20 | Determined by adverse events, vital signs and clinical laboratory parameters in relation to study intervention. |
| Secondary | PFS | From treatment initiation to the earlier of disease progression or death due to any cause. Up to 2 years from last patient enrollment | Progression Free Survival (PFS) |
| Secondary | OS | From treatment initiation to date of death (whatever the cause). Up to 2 years from last patient enrollment | Overall Survival (OS) |
| Secondary | Overall response rate (ORR) | From Screening and up to 2 years from last patient enrollment | The fraction of patients who experience a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per IMWG 2016 criteria. |
| Secondary | Duration of response (DOR) | From initiation of treatment and up to 2 years from last patient enrollment | Time of first evidence of PR or better to confirmation of PD or death due to any cause |
| Secondary | Time to progression (TTP) | From initiation of treatment and up to 2 years from last patient enrollment | From initiation of treatment to documented PD |
| Secondary | Clinical benefit response (CBR) rate | From initiation of treatment and up to 2 years from last patient enrollment | Defined as ORR or minimal response (MR) |
| Secondary | Disease control rate (DCR), | From initiation of treatment and up to 2 years from last patient enrollment | Defined as ORR or minimal response (MR) or stable disease (SD) lasting at least 8 weeks. |
| Secondary | Changes in Global Health Status and Quality of Life | From Screening and up to 2 years from last patient enrollment | The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-MY20 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-MY20 include 20 questions (items). Score scale is starting from minimum of 1 and up to a maximum of 4. Higher values represent a worse outcome.It is the complementary module of the QLQ-C30 which is specific for Multiple Myeloma patients. |
| Secondary | Changes in Global Health Status and Quality of Life | From Screening and up to 2 years from last patient enrollment | The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-C30 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-C30 include 30 questions score scale is starting from minimum of 1 and up to a maximum of 7. In most items (1-28) Higher values represent a worse outcome.The exceptions are the items contributing to the global health status / QoL - 2 items (29-30) In which Higher values represent a better outcome . It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33619369 | 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/NCT04065789
GET https://conductscience.org/api/trials/v1/NCT04065789/registered