Trial · NCT07891923
Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
NCT07891923, Phase 2, Recruiting, Tata Memorial Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma. Trials, record NCT07891923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891923
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
- NCT number
- NCT07891923
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 52 participants, estimated
- Lead sponsor
- Tata Memorial Centre
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Interventions
- Daratumumab (Intravenously), Bortezomib (BTZ), Len (lenalidomide), Dexamethasone
- First posted
- 2026-10-23
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-induction MRD negativity rate | At the end of Cycle 4 (each induction cycle is 28 days; MRD assessed within 2 weeks after completion of Cycle 4 [approximately Days 113-127] | Proportion of participants achieving measurable (minimal) residual disease (MRD) negativity at the end of four cycles of induction therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone (Dara-VRd). MRD negativity will be assessed |
| Secondary | Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate After Four Cycles of Induction | At the end of Cycle 4 (each induction cycle is 28 days; response assessed between Days 107 and 112). | ORR (defined as the proportions of subjects who achieved PR or better) and ≥CR (as per the IMWG criteria) After 4 cycles post-induction |
| Secondary | Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate Day 100 (±15 days) post-transplant | Day 100 (±15 days) following autologous hematopoietic stem cell transplant | ORR (defined as the proportions of subjects who achieved PR or better) and ≥CR (as per the IMWG criteria) at day100 (± 15 days) post-transplant |
| Secondary | Progression-Free Survival (PFS) | From treatment initiation through 2 years of follow-up. | Progression-free survival (PFS), defined as the time from treatment initiation to documented disease progression or death from any cause, whichever occurs first. |
| Secondary | Incidence of Grade ≥3 Adverse Events | Up to 4 weeks after the last dose of study treatment. | Incidence of treatment-emergent Grade 3 or higher adverse events, as assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. |
| Secondary | Minimal residual disease (MRD)Negativity at Day 100 (±15 Days) Post-Autologous Stem Cell Transplantation (ASCT) | Day 100 (±15 days) following autologous stem cell transplantation (ASCT). | Proportion of participants who achieve measurable (minimal) residual disease (MRD) negativity at Day 100 (±15 days) following autologous stem cell Transplantation (ASCT), as assessed using the protocol-specified validated MRD assay |
| Secondary | Sustained MRD negativity | 1 year apart (non-ASCT pts) | Sustained MRD negativity (1-year apart) in patients who do not undergo ASCT |
| Secondary | pharmacokinetics (pK) of daratumumab | From Day 1 (first daratumumab dose) through Day 106 (completion of PK sampling after the sixth daratumumab dose). | To evaluate pharmacokinetics (pK) of daratumumab The Pharmacokinetic study will be carried out during the 1st, 3rd and 6th dose of daratumumab. Its time points are 1st dose (day 1): Pre-dose, end of infusion (EOI), EOI + 2 h, EOI + 5 h, and EOI + 24 h; any time during days 4 and 8; before the second pre-dose (day 15). 3rd dose (day 29): Pre-dose, end of infusion (EOI), EOI + 24 h; any time during days 36 and 43. 6th dose (day 92): Pre-dose, end of infusion (EOI), EOI + 24 h; any time during days 99 and 106. |
| Secondary | Stem-cell yield after mobilization | During stem-cell mobilization and collection, up to 6 months after completion of four cycles of induction therapy and prior to ASCT. | Proportion of participants who achieve a stem cell collection yield of ≥5 × 10⁶ CD34+ cells/kg body weight following mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor. |
| Secondary | Time to Engraftment Following Autologous Stem Cell Transplantation (ASCT) | From the date of autologous stem cell transplantation (ASCT) until hematopoietic engraftment, assessed up to approx day 30 days after ASCT. | Time from autologous stem cell transplantation (ASCT) to hematopoietic engraftment, defined as the first day of achieving an absolute neutrophil count (ANC) ≥0.5 × 10⁹/L and a platelet count ≥20 × 10⁹/L without platelet transfusion support, according to institutional criteria. |
Source ClinicalTrials.gov
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.
Papers20
The papers the trial lists on ClinicalTrials.gov.
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/NCT07891923
GET https://conductscience.org/api/trials/v1/NCT07891923/registered