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NCT00747877

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

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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 Description

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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.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma stage I multiple myeloma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive high-dose melphalan IV on day -1 followed by autologous stem cell transplantation (ASCT) on day 0.

Group Type EXPERIMENTAL

melphalan

Intervention Type DRUG

Given IV

autologous hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Arm II

Patients receive low-dose cyclophosphamide IV or orally once a week for 12-20 weeks for a total of 12 courses.

Group Type EXPERIMENTAL

cyclophosphamide

Intervention Type DRUG

Given orally

Interventions

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cyclophosphamide

Given orally

Intervention Type DRUG

melphalan

Given IV

Intervention Type DRUG

autologous hematopoietic stem cell transplantation

Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other prior therapy for relapsed disease except for local radiotherapy, therapeutic plasma exchange, or ≤ 200 mg of dexamethasone

* Radiotherapy since prior transplantation sufficient to alleviate or control pain of local invasion is permitted
* No hemi-body radiation since prior transplantation (consolidation phase)
* At least 4 weeks since prior and no concurrent investigational drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Gordon Cook, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leeds Cancer Centre at St. James's University Hospital

Locations

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Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Site Status RECRUITING

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status RECRUITING

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Site Status RECRUITING

Royal Bournemouth Hospital

Bournemouth, England, United Kingdom

Site Status RECRUITING

Bradford Royal Infirmary

Bradford, England, United Kingdom

Site Status RECRUITING

Frenchay Hospital

Bristol, England, United Kingdom

Site Status RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status RECRUITING

St. Helier Hospital

Carshalton, England, United Kingdom

Site Status RECRUITING

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status RECRUITING

Saint Richards Hospital

Chichester, England, United Kingdom

Site Status RECRUITING

Colchester General Hospital

Colchester, England, United Kingdom

Site Status RECRUITING

Dorset County Hospital

Dorchester, England, United Kingdom

Site Status RECRUITING

Russells Hall Hospital

Dudley, England, United Kingdom

Site Status RECRUITING

Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

Site Status RECRUITING

Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

Site Status RECRUITING

Ipswich Hospital

Ipswich, England, United Kingdom

Site Status RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status RECRUITING

Royal Liverpool University Hospital

Liverpool, England, United Kingdom

Site Status RECRUITING