NCT00352742

Brief Summary

The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

10 active sites

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

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

Enrollment Period

2.3 years

First QC Date

July 13, 2006

Last Update Submit

October 27, 2008

Conditions

Multiple Myeloma

Keywords

Multiple myelomabortezomibATN-224refractoryrelapsedantiangiogenic

Outcome Measures

Primary Outcomes (2)

  • Phase I: Determine a safe dose of ATN-224 and bortezomib to be used in the phase II portion of the study

    Ongoing

  • Phase II: Efficacy

    End of Study

Secondary Outcomes (2)

  • Phase I: Preliminary evidence of efficacy

    End of Study

  • Phase II: progression-free survival and duration of response

    End of Study

Study Arms (1)

1

EXPERIMENTAL

ATN-224 + bortezomib

Drug: ATN-224 + bortezomib

Interventions

ATN-224 + bortezomibDRUG

ATN-224 and bortezomib dose to be determined in Phase I portion of study

1

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed multiple myeloma that has been treated with at least one different prior anti-myeloma regimens including one with bortezomib and is currently showing evidence of progressive disease
  • Myeloma that is refractory to the most recent bortezomib-containing regimen as demonstrated by progressive disease while on bortezomib or that relapsed within 12 weeks of the last dose of bortezomib either as a single agent or in combination with other agents
  • Measurable disease defined as a serum M-protein concentration on electrophoresis ≥1 g/dL of IgG myeloma or ≥0.5 g/dL of IgA myeloma or IgM myeloma or urinary excretion of monoclonal light chain ≥200 mg/24 hours
  • Age \>18 years
  • Life expectancy of greater than 3 months
  • ECOG performance status \<2 (Karnofsky \>60%; see Appendix A)
  • Adequate organ and marrow function as defined below:
  • absolute neutrophil count ≥1,000/uL
  • platelets ≥75,000/uL
  • hemoglobin ≥8 g/dL
  • total bilirubin ≤2 X institutional upper limit of normal (ULN)
  • AST(SGOT) and ALT(SGPT) ≤3 X ULN
  • creatinine clearance ≥30 mL/min (measured or calculated)
  • Patients are allowed to receive blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to ≥8 g/dL to meet eligibility criteria.
  • Use of adequate contraception. The effects of ATN 224 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of ATN 224.
  • +2 more criteria

You may not qualify if:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or thalidomide, lenalidomide, dexamethasone, arsenic trioxide, bortezomib, or glucocorticosteroids within 3 weeks prior to the first dose of ATN-224 or failure to recover from reversible adverse events due to agents administered previously
  • Patients who cannot tolerate, based on previous experience, the assigned dose of bortezomib, including those with ≥ Grade 2 neuropathy
  • Concurrent administration of any other investigational agents
  • History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
  • Ineligible to receive omeprazole (Prilosec® OTC) or other long-acting antacid
  • Inability to swallow study medication capsules
  • Not a suitable candidate in the opinion of the investigator for additional bortezomib therapy
  • Other serious medical or psychiatric illness preventing informed consent or intensive treatment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women who are pregnant or lactating
  • Known history of HIV
  • History of another prior cancer, except basal cell carcinoma or carcinoma in situ of the cervix (or if there has been no evidence of recurrence for at least 5 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hematolgy-Oncology Medical Group of Fresno, Inc.

Fresno, California, 93720, United States

Location

Institute for Myeloma and Bone Cancer Research

West Hollywood, California, 90069, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

SUNY Downstate

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Interventions

tetrathiomolybdateBortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms 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

Study Officials

  • Gilad Gordon, MD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 17, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

October 28, 2008

Record last verified: 2008-10

Locations

US(10)