The Carthadex trial.

Carfilzomib in combination with Thalidomide and Dexamethasone for remission induction and consolidation of Multiple Myeloma at first presentation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25987

Enrollment

145

Registered

2010-07-22

Start date

2010-07-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Induction cycles: 1. Carfilzomib 20/27mg/m2 days 1,2,8,9,15,16 of a 28 day cycle

2. Thalidomide 200 mg days 1-28 of a 28 day cycle

3. Dexamethasone 20 mg days 1,2,8,9,15,16 of a 28 day cycle. 4. 4 cycles. Stem Cell Harvest. HDM 200mg/m2 ASCT. Consolidation cycles: 1. Carfilzomib 27mg/m2 days 1,2,8,9,15,16 of a 28 day cycle

2. Thalidomide 50 mg days 1-28 of a 28 day cycle

3. Dexamethasone 20 mg days 1,2,8,9,15,16 of a 28 day cycle

4. 4 cycles. Fifty patients will be included in the study cohort. Extensive molecular (FISH) characterization and gene expression profiling of the myeloma tumor cells will be performed at inclusion.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a confirmed diagnosis of multiple myeloma stage I to III according to the ISS criteria; 2. Age 18-65 years inclusive; 3. WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions); 4. Negative urine pregnancy test at inclusion if applicable; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known intolerance of Thalidomide; 2. Systemic AL amyloidosis; 3. Non-secretory MM; 4. Waldenstrom's macroglobulinemia or IgM MM; 5. Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression; 6. Severe cardiac dysfunction (NYHA classification II-IV, see appendix III); 7. Severe pulmonary dysfunction; 8. Significant hepatic dysfunction (serum bilirubin 30 mol/L or transaminases 3.0 times normal level), unless related to myeloma; 9. Creatinine clearance (measured or calculated) 3x ULN; 11. ANC 3.

Design outcomes

Primary

Measure	Time frame
Response (Complete response (CR), very good partial response (VGPR), overall response (OR)): 1. After induction prior to HDM/ASCT; 2. After HDM/ASCT prior to consolidation treatment; 3. At end of consolidation treatment.	—

Secondary

Measure	Time frame
1. Efficacy and toxicity of induction treatment; 2. Efficacy and toxicity of consolidation treatment; 3. Feasibility of good quality stem cell harvest; 4. Progression-free survival (PFS).	—

Contacts

Public ContactP. Sonneveld

P.O. Box 2040

p.sonneveld@erasmusmc.nl+31 (0)10 7033589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)