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Trial record 29 of 2571 for:    "Plasma Cell Neoplasm"

High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00637767
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 14, 2008
First Posted Date  ICMJE March 18, 2008
Last Update Posted Date July 8, 2009
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00637767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
  • Disease response, as measured by changes in serum free light chains (in those patients with serum free light chains that are informative)
  • Disease response, including the proportion of patients with partial remission, stable disease, and progressive disease and remission duration (time to disease progression)
  • 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
  • Treatment-related mortality
  • Overall survival
  • Toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous stem cell transplantation
  • 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
  • Development of a dosimetry model based on SPECT and whole body gamma camera imaging
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant
Official Title  ICMJE 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
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 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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma and Plasma Cell Neoplasm
Intervention  ICMJE
  • Drug: melphalan
  • Procedure: autologous hematopoietic stem cell transplantation
  • Radiation: yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 14, 2008)
90
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637767
Other Study ID Numbers  ICMJE CDR0000588063
USCTU-ANTI-CD66
Eudract-2006-003424-12
EU-20820
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Southampton NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kim Orchard, MD University Hospital Southampton NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP