PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma

PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319865

Enrollment

Registered

2006-04-27

Start date

2005-11-30

Completion date

2008-09-30

Last updated

2006-04-27

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma Relapsed

Brief summary

Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.

Detailed description

Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone. We desined prospective multicenter phase 2 study using these combination sequentially.

Interventions

DRUGThalidomide

DRUGAdriamycin

DRUGDexamethasone

DRUGVelcade

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy. * Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day * Age \< 75 * Performance status \</= ECOG 2 * Expected survival \> 6 months * who signs the informed consent

Exclusion criteria

* known hypersensitivity to thalidomide or dexamethasone * known refractoriness to thalidomide + dexamethasone * Previous Velcade therapy * Sepsis * Woman in reproductive age * Serum creatinine \> 2 mg/dL ; 24 hour creatinine clearance \< 30 ml/min; past medical history of kidney transplatation * Peripheral neuropathy \>/= grade 2 * Recurrent DVT or pulmonary embolism * Cardiac ejection fraction \<0.5 : Severe conduction disorder * Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis * Active ulcers in gastrofiberscope

Design outcomes

Primary

Measure	Time frame
Response rate of PAD induction Therapy	—

Secondary

Measure	Time frame
Response rate of PAD followed by Thal/Dex maintenance	—
Progression free survival and Overall survival of PAD/Thal-Dex.	—
To evaluate toxicities of PAD/Thal-Dex	—

Countries

South Korea

Contacts

Primary ContactJae Hoon Lee, M.D.

jhlee@gilhospital.com82-32-460-2186

Backup ContactHee Keun Kang, R.N.

happy@gilhospital.com82-32-460-3655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026