Clinical trial NCT01370434: Two Cycles of PAD Combination by AHCT in MM
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: MM
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2011-06-10
Enrollment: 43
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: response rates and toxicities.
timeFrame: 2.5 years
Secondary outcomes:
measure: hematologic recovery
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Asanbyeongwon-gil, songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Jung-Hee Lee, professor
role: PRINCIPAL_INVESTIGATOR
References: