Evaluation of safety of the combination of high dose melphalan with bortezomib as conditioning regimen for autologous stem cell transplant for multiple myeloma: a clinical phase I study

Phase 1

• Conditions: Multiple myloma

• Registration Number: JPRN-UMIN000012789
• Lead Sponsor: Division of Hematology, Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with abnormalities with liver function: AST >2.5X ULN, ALT >2.5X ULN, T-Bil >2X ULN(except for disease activity) 2) Patients with abnormalities with renal function: CRTNN >2.0 mg/dl 3)Patients with abnormalities in cardiac function or pulmonary function: EF <50%(assessed on cardiac ultrasonography) , %VC <75% 4)Patients with organ dysfunction due to amyloidosis 5)Patients unable to differentiated from primary amyloidosis or POEMS syndrome 6)Patients with previous serious allergy to Bortezomib, Melphalan or dexamethasone 7)Patients with grade 2 or greater neuropathy due to Bortezomib 8)Patients with active infection 9) Patients with active viral hepatitis or HBs-Ag positive 10)Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease 11) Others: Inappropriate patients determined by a principal investigator or sub-investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety untill day 28 after SCT

Secondary Outcome Measures

Name	Time	Method
Overall response rate and Improvement rate of overall response at day 100 after SCT