NCT00464178

Brief Summary

The purpose of this study is to determine whether the combination of bevacizumab and bortezomib have increased efficacy in the treatment of relapsed/ refractory multiple myeloma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
13.5 years until next milestone

Results Posted

Study results publicly available

July 20, 2022

Completed
Last Updated

July 20, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

April 19, 2007

Results QC Date

September 11, 2013

Last Update Submit

June 24, 2022

Conditions

Multiple Myeloma

Keywords

multiple myelomamyelomarelapsed myelomarefractory myelomarelapsed, refractory myelomarelapsed, refractory multiple myelomarefractory multiple myelomarelapsed multiple myelomaB lymphoid malignanciesMyeloma, Plasma-CellMyeloma ProteinshnRNP A1myeloma helix-destabilizing protein, mouseIgC3kappa Jir protein, humangamma 3 myeloma protein Jir, humanM-proteins (Myeloma)M315 myeloma protein, mousemyeloma protein M 315, mouseMcPC603 antibodymyeloma protein McPC603 antibodymultiple myeloma M-proteinsM protein, multiple myelomamyeloma cell activatormyeloma immunoglobulinsmyeloma immunoglobulin M603myeloma immunoglobulin S15myeloma protein A48, mouseA48 myeloma protein, mouseABPC48 myeloma protein, mousemyeloma protein A 48, mousemyeloma protein Dobmyeloma protein M 467myeloma protein M467myeloma protein MOPC 141, mouseMOPC141 myeloma protein, mousemyeloma protein MOPC 173myeloma protein RouIgA2 myeloma protein Roumyeloma protein TEPC15myeloma protein T15myeloma protein TEPC 15myeloma protein W3129myeloma protein WIEmyeloma-associated membrane antigen KMAmyeloma antigen KMAMYEOV protein, humanprotein 460myeloma protein MOPC 460TRAPPC1 protein, humanmultiple myeloma protein 2, humanWis heavy-chain disease protein, humanmyeloma protein Wis, human

Outcome Measures

Primary Outcomes (2)

  • Median Number of Cycles to Tumor Progression (TTP)

    Study Schema: Bortezomib will be administered on Days 1. 4, 8, and 11. Response will be assessed subsequent to each 21-day cycle. Progression is defined using the Bladé criteria, defined progression as an increase of \>25% in paraprotein or urinary light chain excretion (or marrow plasma cell percentage in the marrow

    18 months

  • Overall Survival (OS) - Number of Participants Alive at Study Completion

    The secondary objective of this study is to assess the safely and tolerability of the combination treatment of bevacizumnab and bortezomnib. Adjustments in the dosing schedule of bortezomib would be made for patients with adequate response as per Blade criteria and continue until disease progression or 18 months

    18 months

Study Arms (1)

Bortezomib and bevacizumab

EXPERIMENTAL

Bortezomib will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.

Drug: Bortezomib

Interventions

BortezomibDRUG

Bortezomib will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.

Also known as: Bortezomib will be administered
Bortezomib and bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have been previously diagnosed with multiple myeloma based on Durie-Salmon criteria and/or the diagnostic criteria developed by the International Myeloma Working Group (IMWG).The patient must currently require therapy for relapsed (progressive disease, defined as a 25% increase in M-protein, development of new or worsening of existing lesions or soft tissue plasmacytoma, or hypercalcemia, or relapse from CR. Or patient must have disease that is refractory to most recent therapy. Defined as less than a 50% reduction in serum paraprotein or 90% reduction in urine paraprotein.
  • Must have measurable disease, defined as follows: For secretory multiple myeloma, measurable levels of monoclonal protein: greater than or equal to 0.5g/dL on electrophoresis or greater than or equal to 200mg of monoclonal light chain on a 24 hour protein electrophoresis.
  • Must have had at least one prior line of therapy but no more than three prior lines of therapy.
  • Must understand and voluntarily sign an informed consent form.
  • Must be greater than/equal to 18 years of age at time of signing consent.
  • Must be able to adhere to study visit schedule and other protocol requirements.
  • Must have an ECOG performance status of 0,1or 2
  • Women of Child-bearing potential (WCBP) defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive method; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.
  • All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study.

You may not qualify if:

  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 12 weeks
  • Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure or left ventricular ejection fraction (LVEF) \< 40% (Note: baseline evaluation of LVEF should be performed for any patient who has received \>450mg/m2 of any anthracycline during prior chemotherapy.
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Known CNS disease
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Known hypersensitivity to any component of bevacizumab and/or bortezomib
  • Previously treated with Bortezomib and/or Bevacizumab.
  • Received nitrosoureas within 3 weeks or any other chemotherapy, including thalidomide or clarithromycin, or radiation therapy before enrollment.
  • Received corticosteroids (greater than 10mg/day prednisone or equivalent) within three weeks prior to enrollment.
  • Received immunotherapy or antibody therapy within 8 weeks prior to enrollment.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellRecurrence

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

The study was terminated prior to enrollment completion and formal analysis of the primary objectives was never conducted.

Results Point of Contact

Title
Dr. David Siegel
Organization
Hackensack University Medical Center
DSiegel@hackensackumc.org
551-996-2000

Study Officials

  • David S Siegel, MD, PhD

    The Cancer Center at Hackensack University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 23, 2007

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 20, 2022

Results First Posted

July 20, 2022

Record last verified: 2022-06

Locations

US(1)