Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study

Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study - iPAd theapy for multiple myeloma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001210

Enrollment

Registered

2008-06-26

Start date

2008-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Relapse/Refractory Multiple Myeloma

Interventions

Bortezomib 1.0 mg/m2 or 1.3 mg/m2 on Days 1, 4, 8, and 11, IV Doxorubicin 9 mg/m2 on Day 1 to 4 IV Dexamethasone 20 mg daily on Days 1 to 2, 4 to 5, 8 to 9, and 11 to 12, orally Each cyc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Relapse/refractory multiple myeloma 2.Possible to measure M protein in serum or urine 3.Performance status 0-2 4.Age between 20 and 80 years 5.Adequate organ function 6.Give voluntary written informed consent before enrollment

Exclusion criteria

Exclusion criteria: 1.Use of bortezomib in the previous treatment. 2.History of allergic reactions to compounds containing mannitol, bortezomib, or boron 3.Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol. 4.Active infection requiring treatment 5.Active hepatitis B or C. 6.Under treatment for a cancer other than multiple myeloma 7.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 8.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 9.Peripheral neuropathy> grade 2 10.Pregnant, lactation or potential

Design outcomes

Primary

Measure	Time frame
Safety Complete remission rate	—

Secondary

Measure	Time frame
PR rate PFS Time to response OS	—

Countries

Japan

Contacts

Public ContactYasushi Takamatsu

Fukuoka University Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine

yasushi@fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026