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

NCT00545519 | Completed Phase 1 DMC

• 1 other identifier: 05-0946
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed Or Refractory Multiple Myeloma

Keywords

Multiple Myeloma; Thymoglobulin

Outcome Measures

Primary Outcomes (1)

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

  End of cycle 1 (DLT) and approximately 16 months after start of treatment (MTD)

Secondary Outcomes (4)

• Determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with thymoglobulin

  Day 14, Day 28 and Day 56

• To determine the time to response, duration of response, and time to progression and overall survival

  Until disease progression but no less than 30 days after end of treatment

• To determine the safety and tolerability of thymoglobulin

  30 days after end of treatment

• Assess the changes in lymphocyte apoptosis signaling in treated patients

  Day 28 and Day 56

Study Arms (3)

Dose Level 1

EXPERIMENTAL

Thymoglobulin 2.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4.

Drug: thymoglobulin

Dose Level 2

EXPERIMENTAL

Thymoglobulin 3.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4.

Drug: thymoglobulin

Dose Level 3

EXPERIMENTAL

Thymoglobulin 4.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4.

Drug: thymoglobulin

Interventions

thymoglobulin DRUG

Also known as: Vidaza

Dose Level 1; Dose Level 2; Dose Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple myeloma diagnosed by standard criteria.
• Measurable levels of monoclonal protein in serum (\> 0.5 g/dL) or urine (\> 0.2 g/24 hr).
• At least 2 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
• Age 18 years or older.
• ECOG performance status \<= 2.
• 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
• Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Receiving any other investigational agents.
• Receiving concurrent steroids with a dose equivalent of dexamethasone of \> 200 mg/month, 1.25g/month of prednisone, or 1g/month of solumedrol.
• Pregnant or nursing.
• Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
• 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.
• 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.
• Weight of \<100 kg to avoid exceeding maximum allowed steroid dose.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Washington Unvierstiy in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Multiple Myeloma

Interventions

thymoglobulin; Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ravi Vij, M.D.

  Washington Universtiy in St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)