A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation

A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation - A multi-center, randomised study comparing thalidomide and bortezomib for multiple myeloma as maintenance therapy after autologous stem cell transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003043

Enrollment

200

Registered

2010-01-25

Start date

2010-01-01

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

multiple myeloma

Interventions

Bortezomib 1.3 mg/m2 iv., day 1,8,15,and 22. 6 courses in 35-day cycle. Thalidomide 100 mg/day po. for 180days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with multiple myeloma who have recieved autologous hematopoietic stem cell transplantation for the first time within 3 months. (Including patients who will recieved autologous hematopoietic stem cell transplantation.) 2. Meet the guidelines for administration of Bortezomib at the start of the study treatment. 3. Clinical data at disease onset and before transplantation can be obtained. 4. Maintenance therapy can be started by 4 months after transplantation. 5. Written-informed consent has obtained.

Exclusion criteria

Exclusion criteria: 1. Allergy for thalidomide, Bortezomib, mannitol,and boron. 2. A woman during pregnancy or potential pregnancy 3. Patients unable to comply with safety management procedures of thalidomide. 4. Patients who cannot stop drugs or therapy restricted in this trial. 5. Patients who are recognized as inadaptable for this trial.

Design outcomes

Primary

Measure	Time frame
Response rate 1 year after stem cell transplantation	—

Secondary

Measure	Time frame
Response rate 2 and 3 year after stem cell transplantation. Progression free survival, overall survival, and adverse events.	—

Countries

Japan

Outcome results

None listed

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