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Research Question
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To determine the efficacy of targeted radiotherapy delivered by an Yttrium-90 (90Y)-radio-labelled murine anti-CD66 monoclonal antibody, given in addition to high dose melphalan (200 mg/m^2) in terms of disease response (complete remission rate and change of serum free light chain level pre and post yttrium-90-radio-labelled anti-CD66) in patients undergoing haematopoietic stem cell transplantation (HSCT) for multiple myeloma. (from UKCRN Portfolio)
Additional lay summaries...
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-having-a-radio-labelled-monoclonal-antibody-before-an-autologous-stem-cell-transplant-for-myeloma (from ISRCTN)
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.
(from ClinicalTrials.gov)
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Ethics Approval
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Sorry, not currently available
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Study Design
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Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Multiple Myeloma and Plasma Cell Neoplasm
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Participants Inclusion Criteria
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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
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Participants Exclusion Criteria
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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
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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90
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Birmingham, London, Southampton
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Interventions
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Drug; melphalan; Procedure; autologous hematopoietic stem cell transplantation; Radiation; yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
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Primary Outcome Measures
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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
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Secondary Outcome Measures
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Disease response, as measured by changes in serum free light chains (in those patients with serum free light chains that are informative); No; Disease response, including the proportion of patients with partial remission, stable disease, and progressive disease and remission duration (time to disease progression); No; 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; No; Treatment-related mortality; Yes; Overall survival; No; Toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous stem cell transplantation; Yes; 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; No; Development of a dosimetry model based on SPECT and whole body gamma camera imaging; No; 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; No
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Website
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http://cancer.gov/clinicaltrials/USCTU-ANTI-CD66
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