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

NCT ID: NCT00416273

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

Detailed 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.

Observation group

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

Group Type: EXPERIMENTAL

No intervention

Intervention Type: DRUG

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

Interventions

Bortezomib

Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.

Intervention Type: DRUG

No intervention

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Augsburg, , Germany

Bamberg, , Germany

Berg, , Germany

Berlin, , Germany

Bremen, , Germany

Cologne, , Germany

Dresden, , Germany

Duisburg, , Germany

Erlangen, , Germany

Eschweiler, , Germany

Frankfurt am Main, , Germany

Freiburg im Breisgau, , Germany

Goch, , Germany

Göttingen, , Germany

Greifswald, , Germany

Halle, , Germany

Hamburg, , Germany

Hamm, , Germany

Hanover, , Germany

Homburg, , Germany

Jena, , Germany

Karlsruhe, , Germany

Kempten, , Germany

Kiel, , Germany

Magdeburg, , Germany

Mainz, , Germany

Mutlangen, , Germany

München, , Germany

Münster, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Regensburg, , Germany

Rostock, , Germany

Stuttgart, , Germany

Ulm, , Germany

Villingen-Schwenningen, , Germany

Wiesbaden, , Germany

Würzburg, , Germany

Countries

Germany

References

Straka C, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019 Sep;103(3):255-267. doi: 10.1111/ejh.13281. Epub 2019 Jul 19.

Reference Type: DERIVED

PMID: 31231828 (View on PubMed)

Einsele H, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Engelhardt M, Fischer T, Liebisch P, Straka C. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017 Jun;31(6):1463-1466. doi: 10.1038/leu.2017.83. Epub 2017 Mar 15. No abstract available.

Reference Type: DERIVED

PMID: 28293022 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=242&filename=CR006124_CSR.pdf

Consolidation Therapy with Bortezomib \<= 60 Year Old Patients with Multiple Myeloma

Other Identifiers

26866138MMY3012

Identifier Type: OTHER

Identifier Source: secondary_id

2005-004948-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR006124

Identifier Type: -

Identifier Source: org_study_id