Multiple Myeloma
Conditions
Keywords
MM
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
Interventions
DRUGPAD 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
Sponsors
Cooperative Study Group A for Hematology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rates and toxicities. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hematologic recovery | 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 |
Countries
South Korea
Outcome results
None listed