Last updated on August 2013

High-Dose Melphalan and a Second Stem Cell Transplant or Low-Dose Cyclophosphamide in Treating Patients With Relapsed Multiple Myeloma After Chemotherapy


Brief description of study

RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and bortezomib. It is not yet known whether high-dose melphalan given together with a second stem cell transplant is more effective than low-dose cyclophosphamide in treating patients with relapsed multiple myeloma. PURPOSE: This randomized phase III trial is studying giving high-dose melphalan together with a second stem cell transplant to see how well it works compared with low-dose cyclophosphamide in treating patients with relapsed multiple myeloma after chemotherapy.

Detailed Study Description

OBJECTIVES: Primary - To determine the effect on freedom from disease progression in patients with relapsed multiple myeloma treated with re-induction therapy comprising bortezomib, doxorubicin hydrochloride, and dexamethasone (PAD) followed by a second autologous stem cell transplantation (ASCT) with high-dose melphalan vs low-dose cyclophosphamide consolidation therapy. Secondary - To assess the response rate of PAD in patients following a previous autograft. - To compare the overall response rate of patients following high-dose melphalan chemotherapy and autologous stem cell transplantation with low-dose cyclophosphamide consolidation therapy. - To assess the overall survival of patients treated with this regimen. - To assess the safety and toxicity of a second ASCT in these patients. - To assess the safety and toxicity of PAD in these patients. - To assess the feasibility of stem cell collection following PAD in these patients. - To determine the impact of this regimen on pain and quality of life in these patients. OUTLINE: This is a multicenter study. - Re-induction (PAD) therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, doxorubicin hydrochloride IV continuously on days 1-4, and oral dexamethasone on days 1-4 (and days 8-11 and 15-18 of course 1 only). Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. - Peripheral blood stem cell (PBSC) mobilization and harvest: Within 6-12 weeks, some patients receive cyclophosphamide IV on day 0 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 1 and continuing to time of PBSC harvest. PBSCs are then collected. Patients who successfully complete re-induction therapy and have adequate PBSC mobilization are stratified according to length of first remission or plateau (≤ vs ≥ 24 months) and response to PAD re-induction therapy (stable disease vs ≥ partial response). Patients are randomized to 1 of 2 arms. - Arm I (high-dose melphalan consolidation therapy): Patients receive high-dose melphalan IV on day -1 followed by autologous stem cell transplantation (ASCT) on day 0. - Arm II (low-dose cyclophosphamide consolidation therapy): Patients receive low-dose cyclophosphamide IV or orally once a week for 12-20 weeks for a total of 12 courses. Patients complete the EORTC QLQ-C30 and EORTC QLQ-MY20, the Brief Pain Inventory Short Form (BPI-SF), and the Leeds Assessment of Neuropathic Symptoms and Signs (Self Assessment) Pain Scale (S-LANSS) questionnaires at baseline and after completion of re-induction therapy. Patients are followed monthly for up to 100 days after ASCT or at 30 days after low-dose cyclophosphamide and then every 3 months for 5 years.

Clinical Study Identifier: NCT00747877

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Royal Bournemouth Hospital

Bournemouth, United Kingdom
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Bradford Royal Infirmary

Bradford, United Kingdom
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Frenchay Hospital

Bristol, United Kingdom
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Addenbrooke's Hospital

Cambridge, United Kingdom
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St. Helier Hospital

Carshalton, United Kingdom
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Saint Richards Hospital

Chichester, United Kingdom
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Colchester General Hospital

Colchester, United Kingdom
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Dorset County Hospital

Dorchester, United Kingdom
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Russells Hall Hospital

Dudley, United Kingdom
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Ipswich Hospital

Ipswich, United Kingdom
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Aintree University Hospital

Liverpool, United Kingdom
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Guy's Hospital

London, United Kingdom
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St. George's Hospital

London, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Manchester Royal Infirmary

Manchester, United Kingdom
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James Cook University Hospital

Middlesbrough, United Kingdom
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Royal Victoria Infirmary

Newcastle-Upon-Tyne, United Kingdom
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Nottingham City Hospital

Nottingham, United Kingdom
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Derriford Hospital

Plymouth, United Kingdom
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Rotherham General Hospital

Rotherham, United Kingdom
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Salisbury District Hospital

Salisbury, United Kingdom
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Royal Hallamshire Hospital

Sheffield, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Royal Marsden - Surrey

Sutton, United Kingdom
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Musgrove Park Hospital

Taunton, United Kingdom
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Torbay Hospital

Torquay, United Kingdom
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Arrowe Park Hospital

Wirral, United Kingdom
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Aberdeen Royal Infirmary

Aberdeen, United Kingdom
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Ayr Hospital

Ayr, United Kingdom
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Ninewells Hospital

Dundee, United Kingdom
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Raigmore Hospital

Inverness, United Kingdom
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Crosshouse Hospital

Kilmarnock, United Kingdom
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Ysbyty Gwynedd

Bangor, United Kingdom
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Glan Clwyd Hospital

Rhyl, Denbighshire, United Kingdom
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Singleton Hospital

Swansea, United Kingdom
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Recruitment Status: Open


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