Clinical trial · Interventional
Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
NCT04816526CI-TRIAL-00081353terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma Multiple | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Descartes 08 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Descartes 08
- interventionNames
- Biological: Descartes 08
Primary outcomes (1)
- measure
- Rate of Stringent Complete Response
- timeFrame
- 8 months
- description
- Per IMWG 2016 Response Criteria Summary sCR: Complete response (CR) plus a normal free light chain ratio and no clonal cells in bone marrow (by immunohistochemistry). The FLC ratio must be Kappa/Lambda ≤ 4:1 or ≥ 1:2 after counting at least 100 plasma cells. CR: Negative immunofixation in serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. VGPR: Serum M-protein detectable by immunofixation (not on electrophoresis) or a ≥ 90% reduction in M-protein, with urine M-protein \<100 mg/24 hours. PR: ≥ 50% reduction in serum M-protein and a ≥ 90% reduction in 24-hour urinary M-protein (or to \<200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required. If both M-protein and serum-free light chains are unmeasurable, a ≥ 50% reduction in plasma cells is necessary, provided baseline plasma-cell percentage in bone marrow was ≥ 30%. Overall Response (OR): CR+VGPR+PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years of age or older at the time of enrollment * High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs). Exclusion Criteria: * Patients who are pregnant or lactating. * Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.
References
Publications (0)
Data not yet available
No reference posted for this study.