Clinical trial · Interventional
A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects
NCT01980589CI-TRIAL-00027810CHAMPION 2completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)
- description
- Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- interventionNames
- Drug: Carfilzomib
- Drug: Cyclophosphamide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Number of Participants With Dose-limiting Toxicities (DLTs)
- timeFrame
- First cycle treatment over 28-days
- description
- The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported. Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events: Nonhematologic: * ≥ Grade 3 non-hematological toxicity * ≥ Grade 3 acute kidney injury (creatinine \> 3 × baseline or \> 4.0 mg/dL) lasting \> 72 hours Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10\^9/L) lasting for \> 7 days * Febrile neutropenia (ANC \< 1.0 × 10\^9/L with a fever ≥ 38.3ºC) of any duration * Grade 4 thrombocytopenia (\< 25 × 10\^9/L) that persists for \> 14 days, despite holding treatment * Grade 3 or 4 thrombocytopenia associated with \> Grade 1 bleeding
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed multiple myeloma 2. Measurable disease, as defined by 1 or more of the following * Serum M-protein ≥ 0.5 g/dL, or * Urine M-protein ≥ 200 mg/24 hours, or * In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio 3. Males and females ≥ 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Adequate hepatic function 6. Left ventricular ejection fraction (LVEF) ≥ 40% 7. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L 8. Platelet count ≥ 50 × 10\^9/L 9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min Exclusion Criteria: 1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma 2. Multiple myeloma of immunoglobulin M (IgM) subtype 3. Prior systemic treatment for multiple myeloma 4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg 5. Known amyloidosis 6. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment. 7. Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed) 8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment 9. Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.