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Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients


Phase 2
15 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients


1.PAD combination chemotherapy

- Bortezomib 1.3 mg/m2 will be given by intravenous bolus injection on days 1, 4, 8, 11
of each cycle. Oral or intravenous dexamethasone 40 mg will be administered on days 1-4
and 8-11 with doxorubicin 9 mg/m2 by intravenous bolus on days 1-4 of each cycle. The
cycle will be repeated every 3 weeks. A total of 2 cycles is planed before AHCT.

- For mobilization, G-CSF 10ug/kg/d alone will be given by subcutaneous injection from
day 12 of the second PAD cycle until completion of harvesting.

Melphalan 100 mg/m2/day will be administered on day -3 and day -2 for high-dose
chemotherapy.

-Maintenance :Thalidomide 100 - 200 mg/d for 2 years


Inclusion Criteria:



- Patients with newly diagnosed symptomatic MM (see Appendix I)

- Patients should be eligible for AHCT.

- Patients should have measurable serum or urine paraprotein.

- The performance status of the patients should be 70 or over by Karnofsky
performance scale

- Adequate hepatic and renal function: serum bilirubin < 1.5 x the upper limit of
normal (ULN), serum alanine aminotransferase (ALT)/aspartate aminotransaminase (AST)
values < 2.5 x ULN, serum creatinine < 1.5 x ULN

- Adequate cardiac function: ejection fraction > 40% by echocardiogram or radionuclide
heart scan

Exclusion Criteria:

- prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or
localized radiotherapy or plasmapheresis for the treatment of clinically significant
hyperviscosity syndrome

- have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.

- significant infection

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 rates and toxicities.

Outcome Description:

To investigate the effectiveness of bortezomib, doxorubicin and dexamethasone (PAD) combination therapy in the treatment of previously untreated patients with multiple myeloma who are eligible for autologous hematopoietic cell transplantation (AHCT). The effectiveness will be evaluated in terms of response, response rates, and toxicities.

Outcome Time Frame:

2.5 years

Safety Issue:

Yes

Principal Investigator

Jung-Hee Lee, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

H-34

NCT ID:

NCT01370434

Start Date:

July 2006

Completion Date:

January 2009

Related Keywords:

  • Multiple Myeloma
  • MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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