A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib; Drug: No intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT00416273

CR006124

26866138MMY3012 (Other Identifier)

2005-004948-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Full description

This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.

Enrollment: 217 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
• Women must be postmenopausal or using safe contraception methods
• Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges

Exclusion criteria

• No asecretory multiple myeloma
• History of allergic reactions to bortezomib or mannitol
• Expected life expectancy of less than 3 months
• No other malignant disease beside basalioma either existing or history of
• No history of severe cardio-pulmonary disease
• Seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

Treatment group

Experimental group

Description:

Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.

Treatment:

Drug: Bortezomib

Observation group

Experimental group

Description:

Participants in the observation group will not receive any consolidation therapy.

Treatment:

Drug: No intervention