Trial · NCT07887984
Comparing Bispecific Antibody Treatment to Autologous Stem Cell Transplant for Newly Diagnosed, Standard Risk Multiple Myeloma
NCT07887984, Phase 2, Phase 3, Not yet recruiting, Alliance for Clinical Trials in Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Bispecific Antibody Treatment to Autologous Stem Cell Transplant for Newly Diagnosed, Standard Risk Multiple Myeloma. Trials, record NCT07887984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Bispecific Antibody Treatment to Autologous Stem Cell Transplant for Newly Diagnosed, Standard Risk Multiple Myeloma
- NCT number
- NCT07887984
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 920 participants, estimated
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Multiple Myeloma (MM)
- Interventions
Daratumumab and Recombinant Human Hyaluronidase, Lenalidomide, Bortezomib, Dexamethasone, Autologous Hematopoietic Stem Cell Transplantation, Melphalan, Teclistamab, Talquetamab, Positron Emission Tomography, Computed Tomography, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Magnetic Resonance Imaging
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients who are classified as being MRD-negative post-consolidation (Phase II) | Up to 1 year from registration | Will be defined as the number of patients who are identified as having no detectable minimal residual disease (MRD) (absence of malignant cells at a sensitivity threshold of 10\^-5 or lower using next generation sequencing) after consolidation therapy divided by the total number of evaluable patients on the given treatment arm. Will conduct separate pairwise comparisons of each of the three bispecific antibody (BsAb) treatment arms against the common control arm. |
| Primary | Progression-free survival (PFS) (Phase III) | From date of randomization to the date of documented disease progression and/or death due to any cause, whichever comes first, assessed up to 20 years | Will be evaluated and compared using a log-rank test to compare differences between those randomized to receive the most promising BsAb as consolidation (identified from the phase II portion of this trial) vs. those randomized to receive consolidation with high-dose melphalan/autologous stem cell transplant (ASCT). PFS distributions will be evaluated graphically using the methods of Kaplan and Meier, 4-year PFS rates with corresponding 95% confidence intervals will be estimated. |
| Secondary | Overall survival (OS) (Phase II) | From randomization to the time of death due to any cause, assessed up to 20 years | Kaplan-Meier methods will be used to estimate key aspects and characteristics of the survival distributions. 4 year estimates will be generated along with corresponding 95% confidence intervals. |
| Secondary | ate of conversion from MRD-positive to MRD-negative post-induction to post-consolidation in each treatment arm (Phase II) | Up to 12 months from randomization | Defined as the number of patients converted from MRD-positive after induction to MRD-negative after consolidation therapy divided by the number of patients MRD-positive patients after induction. |
| Secondary | Overall rate of MRD-negativity in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after the start of treatment divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of MRD-negativity after 2 years of maintenance in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve MRD-negativity after maintenance divided by the number of MRD evaluable patients. Patients are evaluable for MRD if they have a trackable clonality sequence at baseline. |
| Secondary | Rate of grade 3+ adverse events in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients with a grade 3+ adverse event divided by the number of patients that received treatment. |
| Secondary | Rate of grade 3+ serious infection in each treatment arm (Phase II) | Within 1 year of starting consolidation | Defined as the number of patients with a grade 3+ infection (CTCAE) divided by the number of patients starting consolidation therapy. |
| Secondary | Progression-free survival (PFS) (Phase II) | From date of randomization to the date of documented disease progression and/or death due to any cause, whichever comes first, assessed up to 20 years | For each treatment arm, 4-year PFS rates with corresponding 95% confidence intervals will be estimated using the method of Kaplan-Meier |
| Secondary | Overall response rate in each treatment arm (Phase II) | Up to 3 years from randomization | Defined as the number of patients who achieve the best response divided by the number of randomized patients to that treatment arm |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
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/NCT07887984
GET https://conductscience.org/api/trials/v1/NCT07887984/registered?page=2