Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00378768
Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma
A Phase 2 study testing anti-thymocyte globulin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- anti-thymocyte globulin
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
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.
Read the 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.
- Being tested
- anti-thymocyte globulin
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startNov 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William I. Bensinger, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378768
- Sponsor's protocol ID
- 2029.00
- Other IDs
- FHCRC-2029.00, GENZ-FHCRC-2029.00, CDR0000500474
- Status last verified
- Nov 2011
- First submitted
- 19 Sep 2006
- Last updated
- 30 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00378768
- Acronym / sponsor ID
- 2029.00
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulin | Biological | – |
Primary outcome
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
2 secondary outcomes
Toxicity as assessed by NCI CTC v2.0
Formation of antirabbit antibodies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William I. Bensinger, MD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.