Trial · NCT07247097

ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma

NCT07247097, Phase 2, Not yet recruiting, Massachusetts General Hospital

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma. Trials, record NCT07247097. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07247097

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
NCT number: NCT07247097
Status: Not yet recruiting
Phases: Phase 2
Enrollment: 160 participants, estimated
Lead sponsor: Massachusetts General Hospital
Conditions: Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Transplant Ineligible, Newly Diagnosed Multiple Myeloma (NDMM)
Interventions: Elranatamab (PF-06863135), Daratumumab and Hyaluronidase-fihj, Lenalidomide, Bortezomib for Injection, Dexamethasone
First posted: 2025-11-25
Last updated: 2026-06-23

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles	Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4.	Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 4 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Progression-Free Survival (PFS)	Day 1 of Cycle 1 (each cycle is 28 days) to documentation of disease progression or death from any cause (up to 5 years). Patients who have not progressed or died are censored at the date last known progression-free.	Progression-free survival (PFS) is the time from randomization to disease progression or death from any cause. PFS distributions will be calculated using the Kaplan-Meier method. PFS will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Overall Survival (OS)	Day 1 of Cycle 1 (each cycle is 28 days) to documentation of death due to any cause or censored at the date last known alive, up to 5 years from study registration.	Overall survival (OS) is the time from start of treatment to death due to any cause. OS distributions will be calculated using the Kaplan-Meier method. OS will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Overall Response Rate (ORR)	Day of initiation of first response to the first documentation of disease progression or death, up to 5 years after registration. Patients who have not progressed or died are censored at the date last known progression-free.	Overall response rate (ORR) is the proportion of patients achieving partial response or better, along with very good partial response and complete response per the International Myeloma Working Group Response Criteria (IMWG). All IMWG response categories will require one confirmation. ORR will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 12 Treatment Cycles	Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 12.	Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 12 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-6 after 4 Treatment Cycles	Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4.	Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-6 after 4 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Proportion Patients who Remain Negative for Minimal Residual Disease (MRD) at 10^-5 for 12 Months	Day of first negative MRD test to study completion (up to 5 years).	12-month sustained MRD is defined as two MRD negative results a minimum of 12 months apart (with a window of four weeks). Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who remain negative for MRD at 10\^-5 for 12 months will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Proportion Patients who Remain Negative for Minimal Residual Disease (MRD) at 10^-6 for 12 Months	Day of first negative MRD test to study completion (up to 5 years).	12-month sustained MRD is defined as two MRD negative results a minimum of 12 months apart (with a window of four weeks). Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who remain negative for MRD at 10\^-6 for 12 months will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-6 after 12 Treatment Cycles	Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 12.	Evaluated at 1 x 10\^-6 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-6 after 12 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.
Secondary	Depth of Response using Peripheral Blood Mass Spectrometry	Day 1 of cycle 1 (each cycle is 28 days) to day 28 of cycle 24.	For the first 50 patients (including the safety run in patients), peripheral blood will be collected for monoclonal protein measurement by mass spectrometry. Mass spectrometry to measure serum monoclonal protein as a form of peripheral blood minimal residual disease (MRD) determination will be compared to the performance of an established assay for measuring minimal residual disease in the bone marrow using next generation sequencing (NGS) by Clonoseq at 10\^-5 threshold. The study will use spectrometry with a clonotypic-based approach using the M-Insight assay.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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