Bortezomib with Dexamethasone compared with oral melphalan and predonisone pluse bortezomib in patients with refractory multiple myeloma: randomized phase 2 study

Bortezomib with Dexamethasone compared with oral melphalan and predonisone pluse bortezomib in patients with refractory multiple myeloma: randomized phase 2 study - PhaseII trial of bortezomib based regimen for multiple myeloma refractory to melphalan-predonine (MP) therapy-Tohoku Myeloma Treatment Organization TOMATO Study-

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003472

Enrollment

Registered

2010-04-09

Start date

2009-10-01

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

myeloma

Interventions

Patients newly diagnosed multiple myeloma will receive melphalan and predonisolone(MP) for 3 cycles. MP therapy consists of oral administration of melphalan at 9mg/m2 on day 1-4 and oral predonisolon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.have given written informed consent. 2.have had diagnosis of symptomatic/non secretary myeloma by IMWG criteria. Or have had diagnosis of myeloma. 3.have measurable lesion. Secretary type: have measurable serum M protein or urine M protein Non secretary type: have measurable lesion > = 2.0 cm in major axes. 4.aged more than 65 years old or aged from 20 to 65 who cannot be candidate for autologous sten cell transplantation. 5.Performance status (ECOG) of 0 to 2 6.Refractory after 3 courses of MP therapy. Refractory is defined as patients whose response is less than PR. 7.Patients with adequately maintained organs functions. A)T-bil, AST, ALT =< 2 times the upper limit of the institution's normal range. B)WBC >= 3000/ul(neutrophil >= 1500/ul), PLT >= 50000/ul, Hb >= 8g/dl C)ejection fraction >=50% D)SatO2 >=94% E)peripheral neuropathy =< grade 1

Exclusion criteria

Exclusion criteria: 1.History of allergic reactions attributed to compounds described in this protocol. 2.History of allergic reaction attributed to bortezomib, mannitol, boron. 3.Active systemic infections requiring treatment. 4.Serious psychiatric illness. 5.Serious respiratory diseases or dysfunction. 6.Suspected with interstitial pneumonia by chest X-P or CT scan. 7.Serious cardiac dysfunction or required treatment. 8.Required hemodialysis not attribute to myeloma. 9.With plasma cell leukemia. 10.Pregnant or lactating. 11.ositive for HBs antigen, HCV antibody, or HIV antibody. 12.Otherwise judged by investigator to be unsuitable.

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
TTP OS PFS CR rate Time to response Duration of response Safety	—

Countries

Japan

Contacts

Public ContactK Ishizawa

Tohoku University Hospital Hematology&Rheumatology

kishizaw@med.tohoku.ac.jp022-717-7165

Outcome results

None listed

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