Clinical trial · Interventional
Carfilzomib, Cyclophosphamide, Dexamethasone in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma
Study of Carfilzomib in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with high risk multiple myeloma have shorter remission periods and reduced overall survival. Prognostic significance of minimal residual disease negative remission is being highlighted in many of the newer studies. The current phase 2 study investigates the combination of carfilzomib together with cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger transplant-eligible patients.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib, , Cyclophosphamide, Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- The combination therapy of Carfilzomib, cyclophosphamide and dexamethasone (KCyd) will be used to treat eligible patients for up to 6 cycles.This will be followed by an autologous bone marrow transplantation and 2 further consolidation cycles of KCyd. Depending on their disease response, patients will be managed expectantly or be started on maintenance.
- interventionNames
- Drug: Carfilzomib, , Cyclophosphamide, Dexamethasone
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 2 years
- description
- To study the progression free survival (PFS) in patients with newly diagnosed high risk multiple myeloma treated with Carfilzomib, Cyclophosphamide and Dexamethasone, followed by autologous bone marrow transplantation.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed Multiple Myeloma AND Transplant eligible AND 2. High Risk as defined by: * International Staging System 3 OR * FISH abnormality of t(4,14), t(14;16), 17p deletion or 1q amp 3. Patients must have evaluable myeloma, with at least one of the following (Assessed within 28 days of commencing the study) * Serum M protein \>/= 0.5g/dL or * Urine M protein \>200mg/24hr * Serum free light chains \>100mg/mL (involved light chain) and abnormal k/l ratio * For IgA patients who have no other means of measurement of disease, sIgA level \>0.75g/dL Exclusion Criteria: 1. Relapsed Myeloma 2. Non transplant eligible patient. 3. IgM subtype Myeloma 4. POEMS syndrome 5. Amyloidosis 6. Waldenstroms Macroglobulinemia 7. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization (Limited site radiation allowed).
References
Publications (0)
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