Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PAD induction · 1 trial · 1 indication
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour
| Arm | Type | Description |
|---|---|---|
| bortezomib; doxorubicin; dexamethasone | EXPERIMENTAL | PAD induction Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1 4 8 \& 11) Doxorubicin 20 mg/m2 i.v. (D1 \& 4) Dexamethasone 20 mg p.o. (D1 2 4 5 8 9 11 \& 12) |
| Name | Type | Description |
|---|---|---|
| PAD induction | DRUG | Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 \& 11), Doxorubicin 20 mg/m2 i.v. (D1 \& 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 \& 12) |
Inclusion Criteria: * Previously diagnosed with multiple myeloma * eligible for autologous stem cell transplantation * meets pre-treatment lab criteria (as defined within protocol). Exclusion Criteria: * Previously received treatment for multiple myeloma (including prior therapy with radiation or...
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PAD induction is a treatment regimen being studied for multiple myeloma. It combines bortezomib, doxorubicin, and dexamethasone as induction therapy in previously untreated patients with the disease. The regimen is currently in clinical development and is not approved by the FDA.
PAD induction is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this regimen for multiple myeloma.
PAD induction is in Phase 2 clinical development. It has completed one Phase 2 trial, which enrolled 107 patients with multiple myeloma. The drug is investigational and has not been approved by regulatory authorities.
PAD induction has one completed clinical trial, NCT00872521, titled 'A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma.' This Phase 2 study enrolled 107 patients in Australia.
No, the clinical trial for PAD induction, NCT00872521, is not randomized and does not use a control group. It is an uncontrolled study, meaning all participants receive the same treatment regimen without comparison to a placebo or standard therapy.