PIANO study

Phase 2

• Conditions: multiple myeloma; D009101

• Registration Number: JPRN-jRCTs031180335
• Lead Sponsor: Kanda Yoshinobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1) Patients diagnosed with symptomatic multiple myeloma
2) Patients who have never received therapy for myeloma, excluding local radiation therapy
3) Patients with measurable disease
(Serum M-protein >= 1g/dL, Urinary M-protein >=200mg/day, or tumor derived-FLC(iFLC)>100mg/L)
4) Performance Status being 0-2. Patients with Performance Status of 3 due to bone lesion are permitted
5) Patients who have the following laboratory values within 14 days before enrollment
1. SpO2 >= 94%
2. neutrophil count >= 1000/mm3
3. platelet count >= 75000/mm3
4. Patients who do not require hemodialysis
5. serum total bilirubin <= 1.5 x upper limit of normal
6. ALT <= 2.5 x upper limit of normal
7. AST <= 2.5 x upper limit of normal
7) Patients who agreed to contraception by an appropriate method
8) Written informed concent has been obtained

Exclusion Criteria

1) Patients with a history of allergy to the drugs used in the protocol therapy
2) Patients who can not be expected to survive more than 3 months
3) Patients who suffered another carcinoma within 5 years
4) Patients with HBs antigen-positive, or HCV antibody-positive, or HIV antibody-positive
5) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more.
6) Patients with serious active infection or patients who are suspected to have serious active infection infections
7) Patients with serious mental disorders
8) Patients with serious pulmonary dysfunction
9) Patients with interstitial pneumonia or pulmonary fibrosis
10) Patients with serious heart dysfunction
11) Patients with poorly controlled diabetes
12) Patients receiving hemodialysis
13) Patient who are or may be pregnant or are nursing
14) Patients who are determined to be inappropriate for study by physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CR rate at day 100 from autologous transplantation

Secondary Outcome Measures

Name	Time	Method
1) overall response rate <br>2) treatment completion rate <br>3) 3-year progression free survival <br>4) 3-year overall survival <br>5) safety