Status:
TERMINATED
High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
European Federation of Pharmaceutical Industries and Associations
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclo...
Detailed Description
OBJECTIVES: Primary * To determine the efficacy of high-dose melphalan (200mg/m²) in combination with targeted radiotherapy delivered by yttrium Y 90 anti-CD66 monoclonal antibody BW250/183, in term...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically proven multiple myeloma (MM)
- Scheduled to undergo autologous hematopoietic stem cell transplantation (HSCT) as consolidation treatment for MM
- Must have sufficient CD34-positive stem cells (≥ 4 x 10\^6 cells per kg body weight) in cryo-storage for two autologous HSCTs
- In partial remission (PR) after prior chemotherapy but before priming therapy for stem cell mobilization
- Patients in complete remission (CR) after prior chemotherapy are not eligible
- Bone marrow cellularity ≥ 20%
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy ≥ 24 weeks
- Hemoglobin ≥ 9.0 g/dL
- Neutrophils ≥ 1,500/mm³
- Platelets ≥ 50,000/mm³
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and/or AST ≤ 2.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception for 4 weeks prior to, during, and for 6 months after completion of study treatment
- Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
- Able to cooperate with study treatment and follow up
- Human anti-mouse antibody (HAMA) negative
- No active uncontrolled infection
- No high-risk non-malignant systemic disease
- No other condition, that in the investigator's opinion, would make the patient an unsuitable candidate for the study
- No known HIV or hepatitis B or C seropositivity
- No history of allergy, including an allergy to rodents or rodent proteins
- No history of eczema or asthma
- No history of New York Heart Association (NYHA) class III or IV cardiac disease
- No congestive heart failure
- PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- Alopecia or certain grade 1 toxicities allowed
- More than 4 weeks since prior radiotherapy (except for localized pain control), endocrine therapy, or immunotherapy
- More than 4 weeks since prior and no other concurrent chemotherapy for the underlying hematological condition, except for the following:
- Cyclophosphamide as priming for stem cell harvest
- Thalidomide
- More than 3 weeks since prior major thoracic and/or abdominal surgery and recovered
- No prior high-dose therapy and autologous HSCT
- Concurrent radiotherapy allowed for the control of bone pain
- The irradiated lesions are not used for response evaluation
- No other concurrent anti-cancer therapy or investigational drugs during transplantation conditioning
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00637767
Start Date
December 1 2007
End Date
October 31 2013
Last Update
December 23 2020
Active Locations (3)
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1
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
2
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
3
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD