Status:
TERMINATED
Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The study involves the use of a targeted form of radiation, in addition to standard high dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is designed to k...
Detailed Description
Patients with multiple myeloma scheduled for standard of care high dose melphalan and autologous stem cell transplant who have an incomplete response to induction treatment (i.e. with measurable disea...
Eligibility Criteria
Inclusion
- Meet established criteria for the diagnosis of multiple myeloma
- Durie-Salmon stage II or III disease
- Measurable disease in the serum and/or urine
- Scheduled to receive high dose chemotherapy and autologous stem cell transplant for multiple myeloma
- Individuals who have previously undergone autologous stem cell transplant are eligible for this study provided more than 6 months have elapsed from the prior transplant.
- Minimum stem cell dose of 4x106 CD34+ MNC / kg stored for autologous stem cell rescue.
- Adequate hematologic reserve as evidenced by ANC ≥ 1500/mm3 and platelets ≥ 100,000/mm3.
- Serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 3x institution upper limit of normal.
- Serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured).
Exclusion
- Stage I or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy
- Non-secretory multiple myeloma
- Pregnant or lactating women
- Males and females who do not agree to practice approved methods of birth control for the duration of the study
- Presence of active infection
- Receipt of previous radiation therapy to critical organs exceeding any of the following limits: kidney 500 cGy, liver 1000 cGy, lungs 500 cGy
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01207765
Start Date
April 1 2008
End Date
June 1 2013
Last Update
March 20 2017
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111