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

NCT00637767 | Terminated Phase 2 DMC

• 3 other identifiers: CDR00005880632006-003424-12EU-20820
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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

  end of study

Secondary Outcomes (9)

• Disease response, as measured by changes in serum free light chains (in those patients with serum free light chains that are informative)

  end of study

• Disease response, including the proportion of patients with partial remission, stable disease, and progressive disease and remission duration (time to disease progression)

  end of study

• 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

  end of study

• Treatment-related mortality

  end of study

• Overall survival

  end of study

Study Arms (2)

radio-labelled anti-CD66 monoclonal antibody

EXPERIMENTAL

Up to 4mg radio-labelled anti-CD66 monoclonal antibody. Plus standard treatment

Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation; Radiation: yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183

No IMP - standard treatment

ACTIVE COMPARATOR

No IMP - standard treatment

Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation

Interventions

melphalan DRUG

No IMP - standard treatment; radio-labelled anti-CD66 monoclonal antibody

autologous hematopoietic stem cell transplantation PROCEDURE

No IMP - standard treatment; radio-labelled anti-CD66 monoclonal antibody

yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183 RADIATION

radio-labelled anti-CD66 monoclonal antibody

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Southampton: lead
• NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust: collaborator
• European Federation of Pharmaceutical Industries and Associations: collaborator
• Bill and Melinda Gates Foundation: collaborator
• The Periscope Consortium: collaborator
• Q-Biologicals NV: collaborator

Study Sites (3)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Melphalan; BW 250 183

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kim Orchard, MD

  University Hospital Southampton NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 18, 2008
• Study Start: December 1, 2007
• Primary Completion: October 31, 2013
• Study Completion: October 31, 2013
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

GB (3)