A Phase I Study Of Thymoglobulin In Patients With Relapsed Or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the maximum tolerated dose and dose limiting toxicity of thymoglobulin in multiple myeloma patients.

To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with Thymoglobulin.

To determine the time to response, duration of response, and time to progression and overall survival of patients treated with Thymoglobulin.

To determine the safety and tolerability of Thymoglobulin in these patients.

To assess the changes in lymphocyte apoptosis and apoptotic signaling in treated patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Thymoglobulin

Criteria

Inclusion Criteria:

1. Multiple myeloma diagnosed by standard criteria.

2. Measurable levels of monoclonal protein in serum (> 0.5 g/dL) or urine (> 0.2 g/24 hr).

3. At least 2 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.

4. Age 18 years or older.

5. ECOG performance status <= 2.

6. Acceptable organ and marrow function as defined below:

• Hemoglobin > 8 gm/dL

• Absolute neutrophil count > 1,000/mm3

• Platelets > 50,000/mm3

• Total bilirubin < 2.5 X institutional upper limit of normal

• AST, ALT < 2.5 X institutional upper limit of normal

• Creatinine < 1.5 X institutional upper limit of normal

• Normal cardiac function as determined by standard institutional methods

7. Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.

8. Ability to understand and the willingness to sign a written informed consent document.

9. Must have demonstrated resistance to steroids equivalent to >160mg/month of dexamethasone, 1g/month of prednisone, or 800mg/month of solumedrol, to insure the effects seen are from thymoglobulin and not the concomitant steroids.

Exclusion Criteria:

1. Receiving any other investigational agents.

2. Receiving concurrent steroids with a dose equivalent of dexamethasone of > 200 mg/month, 1.25g/month of prednisone, or 1g/month of solumedrol.

3. Pregnant or nursing.

4. Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.

5. Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic CNS involvement or psychiatric illness/social situations that would limit compliance with study requirements.

6. History of other malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been off treatment and free from disease for > 3 years.

7. Weight of <100 kg to avoid exceeding maximum allowed steroid dose.