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

Cooperative Study Group A for Hematology

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: PAD combination

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01370434

H-34

Details and patient eligibility

About

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.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

VAD combination

No Intervention group

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).

Treatment:

Drug: PAD combination