Clinical trial NCT00378768: Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
Official title: A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-21
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating patients undergoing stem cell transplant for multiple myeloma.

Detailed description: OBJECTIVES:

Primary

* Determine the response rate at 4 weeks in patients with multiple myeloma treated with anti-thymocyte globulin at least 4 to 6 weeks prior to undergoing conditioning therapy for allogeneic or autologous stem cell transplantation.

Secondary

* Determine the toxicity of this drug, in terms of formation of antirabbit antibodies, in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive anti-thymocyte globulin IV over 6 hours on day 1 and over 4 hours on days 3 and 5. Treatment begins 4 to 6 weeks prior to undergoing conditioning therapy for autologous or allogeneic stem cell transplantation.

After completion of study treatment, patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed multiple myeloma
* Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
* Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
* No malignant CNS disease

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count \> 50,000/mm³
* Creatinine ≤ 2 mg/dL
* Hepatic function ≤ 2 times upper limit of normal
* DLCO ≥ 50%
* No active infection
* No hypersensitivity to rabbit proteins
* No symptomatic hyperviscosity syndrome
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

* More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
* No prior anti-thymocyte globulin
* No concurrent radiotherapy

Primary outcomes:
measure: Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
Secondary outcomes:
measure: Toxicity as assessed by NCI CTC v2.0
measure: Formation of antirabbit antibodies
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: William I. Bensinger, MD
role: PRINCIPAL_INVESTIGATOR
References: