A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039
Sponsor: Millennium Pharmaceuticals, Inc.
This PHASE3 trial investigates Multiple Myeloma and is currently completed. Millennium Pharmaceuticals, Inc. leads this study, which shows 6 recorded versions since 2002 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Apr 2002
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Millennium Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ann Arbor, United States , Antwerp, Belgium , Atlanta, United States , Barcelona, Spain , Belfast, Ireland , Berkeley, United States , Berlin, Germany , Birmingham, United Kingdom , Bonn, Germany , Boston, United States and 58 more locations