Trial · NCT05552222
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
NCT05552222, Phase 3, Recruiting, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma. Trials, record NCT05552222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05552222
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
- NCT number
- NCT05552222
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 1,590 participants, estimated
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Teclistamab, Daratumumab, Lenalidomide, Dexamethasone, Talquetamab
- First posted
- 2022-09-23
- Last updated
- 2026-11-03
- Other registries' IDs
- eudract:2022-000909-28
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization to the date of disease progression or death (Up to 09 years) | PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria. |
| Primary | 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) | At Month 12 | 12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria. |
| Secondary | Very Good Partial Response (VGPR) or Better | From randomization up to 09 years | VGPR or better is defined as the percentage of participants achieving VGPR and CR (including stringent complete response \[sCR\]) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Secondary | Complete Response (CR) or Better | From randomization up to 09 years | CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Secondary | Sustained Minimal Residual disease (MRD)-negative Complete Response (CR) | From randomization up to 09 years | Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by NGS with sensitivity of 10\^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between. |
| Secondary | MRD-negative CR | From randomization up to 09 years | MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10\^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better. |
| Secondary | Progression Free Survival on Next-line Therapy (PFS2) | From randomization up to 09 years | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | From randomization to the date of death (up to 09 years) | OS is defined as the time from the date of randomization to the date of death due to any cause. |
| Secondary | Number of Participants with Adverse Events (AEs) by Severity | From randomization up to 09 years | An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. |
| Secondary | Number of Participants with Abnormalities in Laboratory Parameters | From randomization up to 09 years | Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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/NCT05552222
GET https://conductscience.org/api/trials/v1/NCT05552222/registered