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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PAD combination
Sponsored by
Cooperative Study Group A for Hematology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring MM

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

VAD combination

Arm Description

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).

Outcomes

Primary Outcome Measures

response rates and toxicities.
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 Outcome Measures

hematologic recovery
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

Full Information

First Posted
May 16, 2011
Last Updated
June 9, 2011
Sponsor
Cooperative Study Group A for Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT01370434
Brief Title
Two Cycles of PAD Combination by AHCT in MM
Acronym
PADinMM
Official Title
Two Cycles of Pad Combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) Followed by Autologous Hematopoietic Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cooperative Study Group A for Hematology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAD combination
Arm Type
No Intervention
Arm Description
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 Type
Drug
Intervention Name(s)
PAD combination
Other Intervention Name(s)
-vincristine, -doxorubicin, -dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
response rates and toxicities.
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.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
hematologic recovery
Description
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
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hee Lee, professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Asanbyeongwon-gil, songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.google.co.kr
Description
Two Cycles of PAD Combination by AHCT in MM (PADinMM)

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