Trial · NCT06768489
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
NCT06768489, Phase 1, Recruiting, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma. Trials, record NCT06768489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06768489
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
- NCT number
- NCT06768489
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 276 participants, estimated
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
- Interventions
- JNJ-79635322, Daratumumab, Pomalidomide, Lenalidomide
- First posted
- 2025-01-10
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants with Dose-limiting Toxicity (DLT) | Up to 28 days | DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. |
| Primary | Number of Participants with Adverse Events (AEs) by Severity | Up to 3 Years and 3 months | An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. |
| Primary | Number of Participants with Clinically Significant Laboratory Abnormalities | Up to 3 Years and 3 months | Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported. |
| Secondary | Percentage of Participants With Overall Response Rate | Up to 3 Years and 3 months | Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria. |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate | Up to 3 Years and 3 months | VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response \[sCR\]+ complete response \[CR\]+VGPR) according to the IMWG 2016 criteria. |
| Secondary | Percentage of Participants With CR or Better Response Rate | Up to 3 Years and 3 months | CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
| Secondary | Percentage of Participants With sCR or Better Response Rate | Up to 3 Years and 3 months | sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria. |
| Secondary | Duration of Response (DOR) | Up to 3 Years and 3 months | DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM. |
| Secondary | Time to Response (TTR) | Up to 3 Years and 3 months | TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria. |
| Secondary | Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria | Up to 3 Years and 3 months | Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41100731 | DERIVED |
Source PubMed
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/NCT06768489
GET https://conductscience.org/api/trials/v1/NCT06768489/registered?page=2