Two Cycles of PAD Combination by AHCT in MM

NCT ID: NCT01370434

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-01-31

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

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

PAD combination

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

-vincristine; -doxorubicin; -dexamethasone

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cooperative Study Group A for Hematology

NETWORK

Sponsor Role: lead

Responsible Party

Asan Medical Center

Principal Investigators

Jung-Hee Lee, professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

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

Countries

South Korea

Related Links

http://www.google.co.kr

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

Other Identifiers

H-34

Identifier Type: -

Identifier Source: org_study_id