Trial · NCT07485647
Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
NCT07485647, Phase 2, Recruiting, Eden Biltibo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing. Trials, record NCT07485647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07485647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
- NCT number
- NCT07485647
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Eden Biltibo
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab and Recombinant Human Hyaluronidase, Lenalidomide
- First posted
- 2026-03-20
- Last updated
- 2026-08-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with minimal residual disease (MRD) negative status | 2 years | Determined by next generation sequencing or color flow cytometry per Euroflow standard procedure at sensitivity threshold of 10\^-5. |
| Secondary | Assess MRD dynamics at enrollment, day + 365 and at 2 years, including rate of sustained MRD negativity. | At enrollment, day + 365 and at 2 years | |
| Secondary | Progression-free Survival (PFS) measured from day + 100 post-ASCT. | From day + 100 post-autologous stem cell transplant, up to 6 months post treatment | Noninferiority will be assessed by estimating the two-sided 95% confidence interval for the between-group difference in crude rates of 2-year progression-free survival and checking that the lower bound was not lower than -10%. Will conduct the analysis of progression-free survival by using Kaplan-Meier survival curves. |
| Secondary | Assess patient satisfaction on treatment arm using Functional Assessment of Cancer Therapy (FACT)-G item. | At baseline, cycle 13 day 1, cycle 25 day 1, cycle 37 day 1 and at day 28 follow up (cycle length = 28 days) | Using Functional Assessment of Cancer Therapy-G item. Descriptive analysis will be used to summarize the changes. |
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.
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/NCT07485647
GET https://conductscience.org/api/trials/v1/NCT07485647/registered