Clinical Trials/NCT00148317

NCT00148317

Completed

Phase 2

A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients

Weill Medical College of Cornell University1 site in 1 country38 target enrollmentJune 2005

ConditionsMultiple Myeloma

InterventionsBortezomib dexamethasone liposomal doxorubicin cyclophoshamide filgrastim

DrugsBortezomib dexamethasone liposomal doxorubicin cyclophoshamide filgrastim

Overview

Phase: Phase 2
Intervention: Bortezomib
Conditions: Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
Enrollment: 38
Locations: 1
Primary Endpoint: Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

PRIMARY STUDY OBJECTIVES

To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:
1. Patients post first line therapy
2. Patients with relapsed/refractory disease who are bortezomib-naïve
To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.

SECONDARY STUDY OBJECTIVES

To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients).
To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

November 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must voluntarily sign and understand written informed consent.
•Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I.
•Measurable disease as defined the following:
•For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
•For patients with relapsed/refractory disease, \> 0.5 g/dL serum monoclonal protein, \> 0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
•Age \> or = than 18 years at the time of signing the informed consent form.
•Karnofsky performance status\> or =70% (\>60% if due to bony involvement of myeloma).
•Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(\>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens .
•If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study.
•Life expectancy \> 12 weeks.

Exclusion Criteria

•Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
•Prior treatment with bortezomib.
•Peripheral neuropathy of \> Grade 2 as defined by CTCAE Version 3.0 (see Appendix II)
•History of allergic reactions to compounds containing mannitol, bortezomib, conventional formulation of doxorubicin HCL or the components of DOXIL.
•Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
•NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction within 6 months.
•Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
•Known HIV or hepatitis A, B, or C positivity
•Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
•Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).

Arms & Interventions

Treatment Arm

Intervention: Bortezomib

Treatment Arm

Intervention: dexamethasone

Treatment Arm

Intervention: liposomal doxorubicin

Treatment Arm

Intervention: cyclophoshamide

Treatment Arm

Intervention: filgrastim

Outcomes

Primary Outcomes

Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate)

Time Frame: Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization

Myeloma response criteria developed by Bladé et al. was used to categorize response.

Secondary Outcomes

Progression Free Survival(Date of progression, assessed from start of trial to Final data cut off date (15 April 2011))
Yield of CD34+ Stem Cells(Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection)