Trial · NCT05665140
Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
NCT05665140, Phase 2, Phase 3, Recruiting, University Hopsital Schleswig Holstein Campus Lübeck
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients. Trials, record NCT05665140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05665140
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
- NCT number
- NCT05665140
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- University Hopsital Schleswig Holstein Campus Lübeck
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- Isatuximab, Lenalidomide, Bortezomib, Dexamethasone, autologous stem cell transplant
- First posted
- 2022-12-27
- Last updated
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of minimal residual negativity combined with complete remission rate according to IMWG and EuroFlow criteria | Week 40 after start of induction therapy (18 weeks after randomization). | Minimal Residual Disease (MRD) (less than 1 malignant plasma cell per 1 Mio bone marrow cells based on EuroFLow criteria) and complete remission rate (no paraprotein detectable, Immunfixation negative urine and serum) according to international myeloma working group (IMWG) criteria after high dose chemotherapy or 6 courses of IVRD (Isatuximab, Bortezomib, lenalidomide, Dexamethasone) (week 40) |
| Secondary | PFS | from inclusion till end of overall study | to compare the two arms regarding Progression free survival (PFS) \[ Time Frame: time from study inclusion to progression or death whichever comes first\] from start of therapy till maximum of 5 years after start of trial |
| Secondary | OS | From start to end of overall study | to compare the two arms regarding Overall survival \[ Time Frame: time from study inclusion) to death up to a maximum of 5 years |
| Secondary | Toxicity | From start to end of overall study | Number of adverse events in both arms, Toxicity during induction and maintenance with respect to adverse events of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade \>3 up to 5 years after start of treament |
| Secondary | Response criteria | week 20, week 40, year 1, year 2 | Response according to IMWG criteria at week 20, 40, 1 year and 2 years after start of trial |
| Secondary | Response criteria MRD | week 20, week 40, year 1, year 2 | Rate of MRD negativity (less than 10-5) at week 20, 40, 1 year and 2 years after start of trial |
| Secondary | Quality of life (EORTC-5 questionnaire) | week 20, 40, year 1, year 2 | Quality of Life Assessment \[based on EORTC-5 questionnaire) Time Frame: assessed at baseline, at week 20, 40, 1 year ) and 2 years after start of trial |
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/NCT05665140
GET https://conductscience.org/api/trials/v1/NCT05665140/registered