Two Cycles of PAD Combination by AHCT in MM

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370434
• Other study ID #: H-34
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2011
• Last updated: June 9, 2011
• Start date: July 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2011
• Source: Cooperative Study Group A for Hematology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Asanbyeongwon-gil, songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2.5 years	Yes
Secondary	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	2.5 years	Yes

External Links

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