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

June 9, 2011 updated by: Cooperative Study Group A for Hematology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Asanbyeongwon-gil, songpa-gu
      • Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperative Study Group A for Hematology

Investigators

  • Principal Investigator: Jung-Hee Lee, professor, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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