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

• Status: Terminated
• Trial end date: 2013-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Southampton NHS Foundation Trust; University of Southampton
• Collaborators: Bill & Melinda Gates Foundation Visitor Center; European Federation of Pharmaceutical Industries and Associations; NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust; Q-Biologicals NV; The Periscope Consortium
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Melphalan

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