High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant | Recruiting
High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant
Health Conditions
  • Multiple Myeloma and Plasma Cell Neoplasm
Recruiting
Recruitment Status
NCT00637767
Primary Trial ID Number
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 monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. A stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by the chemotherapy and radiolabeled monoclonal antibody. 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.
Primary Outcome Measures
  • Remission status pre- and post-transplantation, specifically the number of patients who achieve complete remission, as measured by the European Blood and Marrow Transplantation Organization Response Criteria; null
Secondary Outcome Measures
  • Disease response, as measured by changes in serum free light chains (in those patients with serum free light chains that are informative); null; Disease response, including the proportion of patients with partial remission, stable disease, and progressive disease and remission duration (time to disease progression); null; Engraftment quality, as measured by time to recovery of peripheral blood neutrophils to > 500/mm³ and platelets > 50, 000/mm³ and duration of recovery for > 180 days post-transplantation; null; Treatment-related mortality; null; Overall survival; null; Toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous stem cell transplantation; null; Pharmacokinetics of indium In 111 anti-CD66 monoclonal antibody BW250/183 as measured by serial blood samples and serial planar and single-photon emission computed tomography (SPECT) gamma camera imaging of selected organs; null; Development of a dosimetry model based on SPECT and whole body gamma camera imaging; null; 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; null
Research Question
  • 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 monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. A stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by the chemotherapy and radiolabeled monoclonal antibody. 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
90
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; melphalan; null; []; Procedure; autologous hematopoietic stem cell transplantation; null; []; Radiation; yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183; null; []
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
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Scientific Title
A Randomised Phase II Clinical Trial Using Targeted Radiotherapy Delivered by an Yttrium-90 Radio-Labelled Anti-CD66 Monoclonal Antibody With High Dose Melphalan Compared to Melphalan Alone, Prior to Autologous Stem Cell Transplantation for Multiple Myeloma
Secondary Trial Identifying Number
USCTU-ANTI-CD66; Eudract-2006-003424-12; EU-20820
Website
http://cancer.gov/clinicaltrials/USCTU-ANTI-CD66
Study Funded By
University Hospital Southampton NHS Foundation Trust.
Funder Type
Sorry, this information is not available
Study Sponsored By
University Hospital Southampton NHS Foundation Trust.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

14 Mar 2008

Last Updated

07 Jul 2009

Date Record Refreshed on UKCTG

31 Jul 2015