Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Study of JNJ-26866138 (Bortezomib) in Japanese Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to assess the safety/tolerability and determine the Japanese recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.
In Japan, there is no clear treatment guidance for patients with multiple myeloma that
repeatedly relapsed and became refractory. At present, various therapies including other
multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid
massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other
experimental therapies are conducted exploratory as salvage therapies to find the one to
which the patient shows response. Considering that the antitumor activity of JNJ-26866138
against relapsed or refractory MM is clear and and the tolerability is acceptable based on
results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite
meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which
consisting of the two parts: the Phase I part is intended to intravenously administer
JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD
based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is
intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated
at the Japanese RD.
Based on the body surface area calculated before treatment in each cycle, the dose is
calculated for each patient according to the dose level specified by the Patient Enrollment
Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once
daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period
(Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6
cycles in patients expected to show a response.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05027594 -
Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT02412878 -
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma
|
Phase 3 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05971056 -
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
|
N/A | |
| Recruiting |
NCT05243797 -
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
|
Phase 3 | |
| Active, not recruiting |
NCT04555551 -
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Recruiting |
NCT03570983 -
A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion
|
Phase 2 | |
| Completed |
NCT03665155 -
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
|
Phase 1/Phase 2 | |
| Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
| Completed |
NCT02812706 -
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT03792763 -
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03989414 -
A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03608501 -
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
|
Phase 2 | |
| Recruiting |
NCT04537442 -
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT02546167 -
CART-BCMA Cells for Multiple Myeloma
|
Phase 1 |