Two Cycles of PAD Combination by AHCT in MM (PADinMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370434
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
Information provided by:
Cooperative Study Group A for Hematology

May 16, 2011
June 10, 2011
June 10, 2011
July 2006
January 2009   (Final data collection date for primary outcome measure)
response rates and toxicities. [ Time Frame: 2.5 years ]
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.
Same as current
No Changes Posted
hematologic recovery [ Time Frame: 2.5 years ]
To evaluate the feasibility of harvesting peripheral blood stem cells (PBSC) and performing AHCT after 2 cycles of PAD in newly diagnosed MM. Cell counts of harvested PBSC and hematologic recovery after AHCT will be monitored
Same as current
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Two Cycles of PAD Combination by AHCT in MM
Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.

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

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: PAD combination
  • Bortezomib 1.3 mg/m2/d iv on D 1, 4, 8, 11
  • Doxorubicin 9 mg/m2/d iv on D 1-4
  • Dexamethasone 40mg/d po or iv on D1-4, 8-11
Other Names:
  • -vincristine
  • -doxorubicin
  • -dexamethasone
No Intervention: VAD combination
  • vincristine 0.4mg iv on D1-4
  • doxorubicin 9mg/m2 iv on D1-4
  • dexamethasone 40mg/d po on D1-4,9-12,17-20
  • Many physicians use vincristine, doxorubicin, and dexamethasone (VAD) for three to four months as induction therapy (Alexandrian et al, 1990). VAD produces partial response (PR) in about 50% patients, with complete response (CR) observed in 5%-10% patients (Kyle et al, 2004).
Intervention: Drug: PAD combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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AMC, Asan Medical Center
Cooperative Study Group A for Hematology
Not Provided
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center
Cooperative Study Group A for Hematology
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP