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Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma

Information source: Janssen-Cilag G.m.b.H
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Dexamethasone (Drug); Bortezomib (Drug); Cyclophosphamide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen-Cilag G.m.b.H

Official(s) and/or principal investigator(s):
Janssen-Cilag G.m.b.H, Germany Clinical Trial, Study Director, Affiliation: Janssen-Cilag G.m.b.H

Summary

The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.

Clinical Details

Official title: Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone With or Without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to Progression of Disease

Secondary outcome:

Progression-Free Survival (PFS)

Overall Survival (OS)

Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria

Detailed description: This is a prospective, multi-centre, randomized (the study drug is assigned by chance), controlled, open-label (all people involved in the study know the identity of the assigned drug), parallel (each group of patients will be treated at the same time) group phase III study to determine the efficacy of the standard therapy of bortezomib and low dose dexamethasone in combination with or without continuous low dose oral cyclophosphamide for

primary refractory or relapsed myeloma patients (1st - 3rd relapse). The study will consist

of screening period, which may last from day - 14 until day -1 before application of the

first dose of bortezomib (on cycle 1, day 1), treatment phase begins on cycle 1 day 1 and continues until completion or discontinuation of all study drugs and follow-up phase. All patients will be followed up after end of treatment regardless of their response. Eligible patients will be randomized in 1: 1 ratio to receive either treatment arms (Group A: receiving bortezomib plus dexamethasone or Group B receiving bortezomib plus dexamethasone plus cyclophosphamide). Patients will receive up to eight 3-weeks treatment cycles, unless they experience either unacceptable toxicity or if the patients request to withdraw from the study. The maximum number of cycles is dependent on patient response and investigator's discretion. It is recommended that patients with a confirmed complete response (CR) receive 2 additional cycles beyond a confirmation. Patients who do not achieve a CR but a partial response will receive a total of 8 cycles. For patients achieving stable disease it is within the investigator's discretion to continue study treatment beyond 6 cycles, after discussion with the sponsor. After completion of treatment the patients will be followed up every 12 weeks for up to 72 weeks. If the study is still ongoing a further follow up period will be done every 26 weeks until study end, or until the patient reaches progressive disease or start of alternative anti-myeloma therapy, if earlier. In case progressive disease (PD) has already been established during the treatment phase the patients will not enter the follow-up phase. In case of PD or start of alternative anti-myeloma treatment before the end of study the follow-up phase will be discontinued for the patient but the date of death of the patient will be documented (if applicable) before the end of study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Previously diagnosed with multiple myeloma

- Primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of

therapy

- Karnofsky performance status must be equal to 60 percentage (ie, better or equal

performance than requiring some help and taking care of most personal requirements)

- Has life expectancy estimated at screening must be of at least 6 months

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Not received more than three previous lines of therapy for multiple myeloma

- Not received nitrosoureas or any other chemotherapy or immunotherapy or antibody

therapy for multiple myeloma within 6 to 8 weeks before enrolment. Plasmapheresis must not be applied within 2 weeks before enrolment

- Patients with peripheral neuropathy or neuropathic pain of Grade 2 or greater

intensity

- Patients with poorly controlled cardio vascular, vascular, pulmonary,

gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic diseases or hematological disorders

- Not have oligosecretory or non-secretory multiple myeloma

Locations and Contacts

Augsburg, Germany

Berlin, Germany

Bielefeld, Germany

Bremerhaven, Germany

Darmstadt, Germany

Donauwörth, Germany

Dresden, Germany

Frankfurt, Germany

Halle, Germany

Hamburg, Germany

Hamm, Germany

Hannover, Germany

Hildesheim, Germany

Hof, Germany

Koblenz, Germany

Köln, Germany

Lebach, Germany

Leer, Germany

Lübeck, Germany

Magdeburg, Germany

Mannheim, Germany

Moers, Germany

München, Germany

Münster, Germany

Neunkirchen, Germany

Offenburg, Germany

Oldenburg, Germany

Osnabrück, Germany

Passau, Germany

Porta Westfalica, Germany

Ravensburg, Germany

Rostock, Germany

Saarbrücken, Germany

Singen, Germany

Stuttgart, Germany

Velbert, Germany

Weiden, Germany

Wiesbaden, Germany

Würselen, Germany

Würzburg, Germany

Additional Information

Starting date: January 2009
Last updated: July 31, 2014

Page last updated: August 23, 2015

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