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


Phase 2
N/A
75 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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.


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate of PAD induction Therapy

Principal Investigator

Jae Hoon Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korean Multiple Myeloma Working Party

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

KMM55

NCT ID:

NCT00319865

Start Date:

November 2005

Completion Date:

September 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma Relapsed
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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