Trial · NCT05979363
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
NCT05979363, Phase 2, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia. Trials, record NCT05979363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05979363
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
- NCT number
- NCT05979363
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Conditions
- Plasma Cell Leukemia
- Interventions
- anti-BCMA CAR-T, VRD-based regimen
- First posted
- 2023-08-07
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability | Up to 2 year | The incidence of treatment-emergent adverse events (TEAEs) |
| Primary | MRD-negative rate | within 1 week after consolidation treatment | achieving MRD-negative, as determined by NGF after consolidation treatment |
| Secondary | Complete response rate (CRR) | within 1 week after induction therapy, 1 month after the CAR-T cell transfusion, within 1 week after consolidation therapy | CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria |
| Secondary | Progression free survival (PFS) | Up to 2 year | Progression free survival is defined as the time from the date of enrollment to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first |
| Secondary | Overall Survival (OS) | Up to 5 year | Overall survival is measured from the date of enrollment to the date of the participant's death. |
| Secondary | Duration of Remission(DOR) | Up to 2 year | Duration of response is defined as the time from the first documented partial response (PR) or better to disease progression or death from any cause, whichever occurs first. |
| Other | The duration of CART cell in vivo | Up to 1 year | The copies of BCMA-CART DNA in peripheral blood with qPCR method |
| Other | Change from Baseline in Physical status assessed by International Myeloma Working Group Comprehensive Geriatric Assessment (IMWG-CGA) scores | Baseline up to 5 years | The IMWG-CGA was calculated by combining age, activities of daily living (ADL), instrumental ADL (IADL), and Charlson Comorbidity Index (CCI), which ranges from 0 to 5 with higher scores indicating worse physical condition and greater weakness. |
| Other | Change from Baseline in Physical status assessed by activities of daily living (ADL) scores | Baseline up to 5 years | The ADL includes 4 items (transfer, bed mobility, toileting, and eating), which range from 0 to 6 scores. A higher score represents worse physical condition and greater weakness. |
| Other | Change from Baseline in Physical status assessed by instrumental activities of daily living (IADL) scores | Baseline up to 5 years | The IADL includes 5 items (cooking, cleaning, transportation, laundry, and managing finances), which range from 0 to 8 scores. A higher score represents worse physical condition and greater weakness. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT05979363
GET https://conductscience.org/api/trials/v1/NCT05979363/registered