Trial · NCT06997081
ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0)
NCT06997081, Phase 2, Recruiting, University of Miami
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0). Trials, record NCT06997081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06997081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0)
- NCT number
- NCT06997081
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 104 participants, estimated
- Lead sponsor
- University of Miami
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide, Dexamethasone, Elranatamab
- First posted
- 2025-05-30
- Last updated
- 2026-09-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal residual disease (MRD) (10^-5 sensitivity) | Up to 2 years | Minimal residual disease (MRD) is defined as 0 residual clonal cells in a bone marrow biopsy sample MRD negativity (10\^-5 sensitivity) after 12 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment. |
| Secondary | Best Overall Response | Up to 24 months | The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Will be measured during the first 12 and 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment. Will be measured in months. |
| Secondary | Sustained MRD Negativity | Up to 2 years | The sustained rate of MRD-negativity among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result. |
| Secondary | Minimal residual disease (MRD) (10^-6 sensitivity) | Up to 2 years | Minimal residual disease (MRD) negativity ( 10\^-6 sensitivity) is defined as 0 residual clonal cells in a bone marrow biopsy anytime in the first 24 cycles, in participants who have been newly diagnosed with Multiple Myeloma receiving Lenalidomide and Low-Dose Dexamethasone (ERd) combination treatment. |
| Secondary | Progression-Free Survival (PFS) | Up to 24 months | Progression-free survival (PFS) among study participants will be assessed during treatment and clinical follow-up. PFS is defined as the time in months from start of treatment until disease progression or death. |
| Secondary | Overall Survival | Up to 24 months | Overall survival (OS) among study participants will be assessed during treatment and clinical follow-up. OS is defined as the time in months from start of treatment until death from any cause. |
| Secondary | Incidence of Cytokine Release Syndrome (CRS) | Up to 2 years | Incidence of cytokine release syndrome (CRS), grade of CRS, and management of potentially recurring CRS. CRS will be evaluated according to the standards released by American Society for Transplantation and Cellular Therapy (ASTCT) criteria in 2019. |
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/NCT06997081
GET https://conductscience.org/api/trials/v1/NCT06997081/registered