A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Prednisolone; Drug: JNJ-26866138 1.3 mg/m2; Drug: JNJ-26866138 1.0 mg/m2; Drug: Melphalan; Drug: JNJ-26866138 0.7 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985959

CR014776

JNJ-26866138-JPN-MM-102 (Other Identifier)

Details and patient eligibility

About

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).

Full description

This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.

Enrollment: 101 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

Phase I: JNJ-26866138 0.7 mg/m2

Experimental group

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.

Treatment:

Drug: JNJ-26866138 0.7 mg/m2

Drug: Melphalan

Drug: Prednisolone

Phase I: JNJ-26866138 1.0 mg/m2

Experimental group

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

Treatment:

Drug: Melphalan

Drug: JNJ-26866138 1.0 mg/m2

Drug: Prednisolone

Phase I: JNJ-26866138 1.3 mg/m2

Experimental group

Description:

JNJ-26866138 1.3 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

Treatment:

Drug: Melphalan

Drug: JNJ-26866138 1.3 mg/m2

Drug: Prednisolone

Phase II: JNJ-26866138 1.3 mg/m2

Experimental group

Description:

JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Treatment:

Drug: Melphalan

Drug: JNJ-26866138 1.3 mg/m2

Drug: Prednisolone