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Completed

NCT Number: NCT01370434

Two Cycles of PAD Combination by AHCT in MM

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAD combination

Drug
  • 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cooperative Study Group A for Hematology

Network

Registry information

Official study title

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

Acronym: PADinMM

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2011
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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