High-Dose Melphalan and a Second Stem Cell Transplant or Low-Dose Cyclophosphamide in Treating Patients With Relapsed Multiple Myeloma After Chemotherapy
|ClinicalTrials.gov Identifier: NCT00747877|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 5, 2008
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: cyclophosphamide Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Masking:||None (Open Label)|
|Official Title:||Myeloma X Relapse (Intensive): A Phase III Study to Determine the Role of a Second Autologous Stem Cell Transplant as Consolidation Therapy in Patients With Relapsed Multiple Myeloma Following Prior High-dose Chemotherapy and Autologous Stem Cell Rescue.|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2012|
U.S. FDA Resources
Experimental: Arm I
Patients receive high-dose melphalan IV on day -1 followed by autologous stem cell transplantation (ASCT) on day 0.
Given IVProcedure: autologous hematopoietic stem cell transplantation
Patients undergo autologous hematopoietic stem cell transplantation on day 0.
Experimental: Arm II
Patients receive low-dose cyclophosphamide IV or orally once a week for 12-20 weeks for a total of 12 courses.
- Time to disease progression
- Response rate to bortezomib, doxorubicin hydrochloride, and dexamethasone (PAD)
- Overall response rate following randomized treatments
- Overall survival
- Progression-free survival
- Toxicity and safety of autologous stem cell transplantation
- Toxicity and safety of weekly cyclophosphamide
- Toxicity and safety of PAD therapy
- Feasibility of stem cell collection
- Quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747877
Show 53 Study Locations
|Principal Investigator:||Gordon Cook, MD, PhD||Leeds Cancer Centre at St. James's University Hospital|