NCT00378768

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

September 19, 2006

Last Update Submit

November 28, 2011

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Toxicity as assessed by NCI CTC v2.0

  • Formation of antirabbit antibodies

Interventions

anti-thymocyte globulinBIOLOGICAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Antilymphocyte Serum

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • William I. Bensinger, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

November 1, 2005

Study Completion

June 1, 2007

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)