Trial · NCT04352205
Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure
NCT04352205, Phase 2, Terminated, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure. Trials, record NCT04352205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04352205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure
- NCT number
- NCT04352205
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Plasma Cell Myeloma, Renal Failure
- Interventions
- Bortezomib, Daratumumab, Dexamethasone, Lenalidomide, Thalidomide
- First posted
- 2020-04-20
- Last updated
- 2024-07-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in creatinine clearance | Screening until end of Cycle 4 at day 1(12 weeks), each cycle=21 days | Renal function comparisons of creatinine clearance between methods for the cohort will be conducted, with the primary objective of change from baseline, using the same formula, serving as the analysis dataset. |
| Secondary | Pharmacokinetic parameters of Cmax | Cycle 1 at day 1 (12 weeks) to Cycle 2 at Day 15 (12 Weeks), each cycle=21 days | Maximum concentrations for each patient obtained at the end of daratumumab infusion. |
| Secondary | Pharmacokinetic parameters of AUC | Starting at Cycle 1 at day 1(12 weeks) to Cycle 2 at Day 15 (12 weeks), each cycle=21 days | Area under the plasma concentration time curve from time 0-24 hours and extrapolated to infinity to understand dose exposures. |
| Secondary | Pharmacokinetic parameters of CI | Cycle 1 at day (12 weeks) 1 to Cycle 2 at Day 15 (12 weeks), each cycle=21 days | Clearance for each patient to assess the effect of renal insufficiency and potential changes with myeloma treatment that includes daratumumab. |
| Secondary | Incidence of adverse events | Through study completion, an average of 1 year | Will track grade 3, 4, and 5 adverse events collected clinically in the routine course of care, with particular interest in those associated with daratumumab. Subject incidence of all treatment emergent adverse events of interest will be tabulated by system organ class and preferred term. Tables of fatal adverse events, serious adverse events, adverse events leading to withdrawal from investigational product, other protocol-required therapies or from study, and adverse events of interest will also be provided. Relevant laboratory and vital sign (temperature, heart rate, respiratory rate, and blood pressure) data will be displayed by visit and time (when available), with Common Terminology Criteria for Adverse Events (CTCAE). Additionally, all laboratory data will be summarized by CTCAE grade, again, with grade 3, 4 and 5 values to be collected. |
| Secondary | Overall response rate | Through study completion, an average of 1 year | All efficacy assessments will follow International Myeloma Working Group (IMWG) uniform response criteria and be performed every cycle. Will be defined as the proportion of best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR). |
| Secondary | Best overall response | Through study completion, an average of 1 year | All efficacy assessments will follow IMWG uniform response criteria and be performed every cycle. |
| Secondary | Progression free survival | Time from randomization date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Will be defined as number of months from subject's first study dose date to the earlier of disease progression or death due to any cause. |
| Secondary | Duration of response | Time from initiation of first response to first documented progression or death, from any cause, whichever came first, assessed up to 100 months | Will be summarized for all subjects overall, by formulation, by dose cohort level, and by formulation and dose cohort level along with 95% confidence intervals when applicable. Duration of therapy, dose density, and frequency of dose holds or reductions will also be recorded. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 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/NCT04352205
GET https://conductscience.org/api/trials/v1/NCT04352205/registered