A phase II trial of PAD (Bortezomib, Doxorubicin and Dexamethasone) induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance.

A phase II trial of PAD (Bortezomib, Doxorubicin and Dexamethasone) induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance, comparing overall response rate to PAD (Bortezomib, Doxorubicin and Dexamethasone).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000296235

Acronym

The PIMMS Trial: The PAD Induction in Multiple Myeloma Stratified Trial

Enrollment

107

Registered

2009-05-18

Start date

2009-01-23

Completion date

2009-11-27

Last updated

2021-11-22

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

Conditions

None listed

Brief summary

The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma

Interventions

Four 21-day cycles of PAD: a combination of bortezomib i.v. (intravenous) 1.3mg/m2 (Days 1,4, 8 and 11), doxorubicin i.v. 20mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12). Days 13 to 21 will be 'rest' days - i.e. no treatment will be given on these days.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Previously diagnosed with multiple myeloma; eligible for autologous stem cell transplantation; meets pre-treatment lab criteria (as defined within protocol).

Exclusion criteria

Previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone), except localised radiation to a solitary lesion or plasmacytomas or 4 days of corticosteroid therapy; have a current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), or Waldenstrom Macroglobulinemia; have a history of any other malignancy within 5 years before enrolment; have other significant comorbidities

Outcome results