High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant
NCT ID: NCT00637767
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2007-12-01
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase II trial is studying how well high-dose melphalan works when given with or without radiolabeled monoclonal antibody in treating patients with multiple myeloma undergoing an autologous stem cell transplant.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 terms of disease response (complete remission rate and change in serum free light chain level before and after treatment with yttrium Y 90 anti-CD66 monoclonal antibody BW250/183), in patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma.
Secondary
* To determine the toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous hematopoietic stem cell transplantation.
* To determine the effect of targeted radiotherapy on other parameters of disease response, in terms of proportion of patients with partial remission, stable disease, and progressive disease, remission duration (time to disease progression), and overall survival.
* To determine the effect of targeted radiotherapy on engraftment when used in combination with high-dose melphalan in patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma.
* To investigate the pharmacokinetic behavior of indium In 111 anti-CD66 monoclonal antibody BW250/183 (used for dosimetry).
* To continue to develop a dosimetry model based on single-photon emission computed tomography (SPECT) and whole body gamma camera imaging following administration of the radiolabeled anti-CD66 monoclonal antibody (in a subset of patients at the Southampton site only).
* To assess the proportion of patients who form human anti-murine antibodies (HAMA) after treatment with targeted radiotherapy in the context of an autologous hematopoietic stem cell transplantation.
OUTLINE: This is a multicenter study. Patients are stratified according to disease risk group (low risk \[beta-2 microglobulin and C-reactive protein \< 6 or either beta-2 microglobulin or C-reactive protein ≥ 6\] vs high risk \[both beta-2 microglobulin and C-reactive protein ≥ 6\]). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive a dosimetry dose of indium In 111 anti-CD66 monoclonal antibody BW250/183 IV on day 1 and undergo gamma camera imaging and serial blood samples on days 1-5. Patients then receive a therapeutic dose of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 IV once between days 9 and 16 and high-dose melphalan IV on day 28. Patients then undergo autologous hematopoietic stem cell transplantation (HSCT) on day 30.
* Arm II: Patients receive high-dose melphalan IV on day 1. Patients then undergo autologous HSCT on day 3.
Patients in arm I undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies and analysis of human anti-murine antibody (HAMA) status.
After completion of study treatment, patients are followed periodically.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
radio-labelled anti-CD66 monoclonal antibody
Up to 4mg radio-labelled anti-CD66 monoclonal antibody. Plus standard treatment
melphalan
autologous hematopoietic stem cell transplantation
yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
No IMP - standard treatment
No IMP - standard treatment
melphalan
autologous hematopoietic stem cell transplantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
melphalan
autologous hematopoietic stem cell transplantation
yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
UNKNOWN
European Federation of Pharmaceutical Industries and Associations
UNKNOWN
Bill and Melinda Gates Foundation
OTHER
The Periscope Consortium
UNKNOWN
Q-Biologicals NV
UNKNOWN
University of Southampton
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kim Orchard, MD
Role: STUDY_CHAIR
University Hospital Southampton NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2006-003424-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EU-20820
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000588063
Identifier Type: -
Identifier Source: org_study_id