Phase 1
Completed N=99
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Source: ClinicalTrials.gov NCT00985959 ↗Enrolled (actual)
99
Serious AEs
32.4%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1) — 0; 0; 1 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1) |
0; 0; 1 | — |
| PRIMARY Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II |
6; 5; 4; 60; 71 | <0.0001 sig |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I |
45.43; 59.42; 120.3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I |
34.40; 69.50; 88.87 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I |
100.2 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I |
1131 | — |
| SECONDARY Median Time to First Response - Phase II |
51 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00985959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.