Carfilzomib, Cyclophosphamide, Dexamethasone in Transplant Eligible Newly Diagnosed High-risk Multiple Myeloma

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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).