Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

NCT ID: NCT00416208

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.

Detailed Description

No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma patients are available. Ínterferon tested as consolidation / maintenance therapy has not uniformly proven to prolong survival. In this study the hypothesis is being tested that bortezomib is able to increase duration of response and thus improving survival. This hypothesis is based on the results of the approval study where bortezomib has been tested to improve these endpoints.This is a multicenter, open-label, randomized (patients are assigned to different treatment group by chance) phase III study to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75. Three months after receiving high dose melphalan with autologous stem cell transplantation patients will be randomized to receive either consolidation therapy with bortezomib or to be monitored without consolidation therapy. Subjects in the consolidation group will be treated up to 4 cycles (6 weeks each). The main study phase has a duration of 24 weeks. The trial ends after the last enrolled patient has completed a follow-up period of 30 months. The primary objective is to determine the event free survival in treatment and observation group. The secondary objectives are to assess the response rate, overall survival, duration of response, time to progression, short- and long-term toxicities, quality of life and cytogenetic analyses with regard to treatment response, event free survival and overall survival. Primary efficacy analysis: Event free survival is defined as the time from the first disease-related therapeutic procedure until death, progress or relapse. Secondary efficacy analyses: response rate of the treatment group (measured by the relative change of M-protein levels in serum or urine); overall survival is defined as the time from the first therapeutic procedure until death; time to progression is defined as the duration from the date of enrolment until the date of first documented evidence of progressive disease or relapse; duration of response is defined as the duration in months from the date of first evidence of confirmed response to the date of first documented evidence of progressive disease or relapse; quality of life is assessed by the questionnaires EORTC QLQ-C30 (Quality of life questionnaire) and EORTC EQ-5D (Euro Quality of life). Consolidation therapy lasts 4 cycles. Subjects will be treated with bortezomib 1.6 mg/m2 body surface intravenously once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35). At least 72 hours should relapse between consecutive doses of bortezomib. Therapy should be withheld at the onset of any Grade 3 nonhematological or Grade 4 hematological toxicities excluding neuropathy.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

Bortezomib

Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days

Observation

Observational arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bortezomib

1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
• at least stable disease after stem cell transplantation
• adequate hematological, hepatic and renal lab parameters
• karnofsky status of 70 or more

Exclusion Criteria

• non-secretory multiple myeloma
• previous treatment with bortezomib
• allogenic stem cell transplantation
• other co-existing malignancy beside basaliome
• peripheral neuropathy
• epilepsia
• other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
• history of allergic reactions to bortezomib or mannitol
• expected life expectancy of less than 3 months

• Minimum Eligible Age: 61 Years
• Maximum Eligible Age: 75 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. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag G.m.b.H

Locations

Bamberg, , Germany

Berg, , Germany

Berlin, , Germany

Bremen, , Germany

Dortmund, , 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

Jena, , Germany

Karlsruhe, , Germany

Kempten, , Germany

Kiel, , Germany

Kÿln N/A, , Germany

Lübeck, , Germany

Magdeburg, , Germany

Mutlangen, , Germany

München, , Germany

Münster, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Regensburg, , Germany

Rostock, , Germany

Stuttgart, , Germany

Trier, , 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=243&filename=CR006127_CSR.pdf

Consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75

Other Identifiers

26866138MMY3013

Identifier Type: OTHER

Identifier Source: secondary_id

CR006127

Identifier Type: -

Identifier Source: org_study_id