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PAD induction

Phase 2

Multiple Myeloma | Small molecule | Oncology |Johnson & Johnson|Trials Updated: May 16, 2014

PAD induction development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

PAD induction clinical trials

PAD induction · 1 trial · 1 indication

Phase 2 1
NCT00872521A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple MyelomaMultiple Myeloma
COMPLETED107 Analytics
PHASE2COMPLETED
A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
84 days

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

Secondary Endpoints

Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
84 days
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
3-months following ASCT
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
3-months after ASCT
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
bortezomib; doxorubicin; dexamethasoneEXPERIMENTALPAD 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)

Interventions

NameTypeDescription
PAD inductionDRUGOpen 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)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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...

Countries:Australia
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Competitive Landscape -Multiple Myeloma 338 trials

Frequently asked questions about PAD induction

What is PAD induction used for?

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.

Who is developing PAD induction?

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.

What phase is PAD induction in?

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.

What clinical trials is PAD induction in?

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.

Is PAD induction a randomized controlled trial?

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.