NCT00036140

Brief Summary

The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2002

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2004

First QC Date

May 8, 2002

Last Update Submit

June 23, 2005

Conditions

Keywords

Pharmacia

Interventions

Eligibility Criteria

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

You may not qualify if:

  • Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment.
  • The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given.
  • Any side-effects from prior chemotherapy must have subsided
  • Blood and urine tests must show adequate bone marrow, liver, and kidney function.
  • Any of the following will exclude patients from study participation:
  • indolent or smoldering myeloma or localized plasmacytoma
  • hyperviscosity syndrome
  • irradiation to 25% or more of bone marrow
  • prior high dose chemotherapy with bone marrow or stem cell support
  • current participation in other clinical trials
  • pregnant or breast-feeding women
  • known HIV-positive or AIDS-related illness
  • patients planning to have radiation therapy or surgery that would interrupt study therapy in the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Center

Los Angeles, California, 90033, United States

Location

Research Center

Los Angeles, California, 90048, United States

Location

Research Center

Rancho Mirage, California, 92270, United States

Location

Research Center

Cleveland, Ohio, 44106, United States

Location

Research Center

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2002

First Posted

May 9, 2002

Last Updated

June 24, 2005

Record last verified: 2004-03

Locations