Clinical trial · Interventional
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
NCT00985959CI-TRIAL-00012788completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-26866138 0.7 mg/m2 | Drug | — | UNRESOLVED |
| JNJ-26866138 1.0 mg/m2 | Drug | — | UNRESOLVED |
| JNJ-26866138 1.3 mg/m2 | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I: JNJ-26866138 0.7 mg/m2
- description
- JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles.
- interventionNames
- Drug: JNJ-26866138 0.7 mg/m2
- Drug: Melphalan
- Drug: Prednisolone
- type
- EXPERIMENTAL
- label
- Phase I: JNJ-26866138 1.0 mg/m2
- description
- JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
- interventionNames
- Drug: JNJ-26866138 1.0 mg/m2
- Drug: Melphalan
- Drug: Prednisolone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Participants diagnosed with symptomatic or nonsecretory multiple myeloma * Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates * Participants with a measurable lesion * Life expectancy greater than or equal to 3 months Exclusion Criteria: * Previously received treatment for Multiple Myeloma * Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain * Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities * Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection * Active prior malignancy diagnosed within the last 5 years * Female participant who is pregnant or breast-feeding * Participant is enrolled in another clinical research study and/or is receiving an investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.