A pilot study to explore the tolerability and efficacy of bortezomib as part of induction and post-transplant therapy in multiple myeloma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000770662

Acronym

BIR

Enrollment

Registered

2005-11-30

Start date

2005-05-31

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study is for patients who have newly diagnosed myeloma to check how effective and safe is velcade.

Interventions

Induction cycle (1) Vincristine, Doxorubicin and Dexamethasone (VAD). Good responders will continue with two more cycles of VAD. Poor responders will have two cycles of bortezomib, Doxorubicin and Dexamethasone (VcAD). Patient will proceed to peripheral blood stem cell mobilisation and transplant. Patients who are not in remission after transplant will receive 2 cycles of single agent bortezomib treatment. All patients will receive prednisolone maintenance for one year post transplant.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 65 Years

Healthy volunteers

Inclusion criteria

Previously untreated, advanced multiple myeloma, planned for autologous PBSCT, absence of significant co-morbidity.

Exclusion criteria

No exclusion criteria

Outcome results