NCT00003603

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

February 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

cyclophosphamideDRUG
dexamethasoneDRUG
idarubicinDRUG
lomustineDRUG
melphalanDRUG
prednisoloneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma based on at least two of the following: * Paraprotein in serum and/or urine * Greater than 10% plasma cells in bone marrow * Lytic bone lesions * Measurable serum and/or urine paraprotein * Progression from first or second stable plateau phase * No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm\^3 circulating plasma cells) * No primary refractory disease or second or later relapse PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-3 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT/AST no greater than 2.5 times ULN Renal: * Creatinine less than 3.4 mg/dL Cardiovascular: * No clinically significant cardiac insufficiency * No uncontrolled hypertension Other: * No uncontrolled diabetes mellitus * No recent history of peptic ulceration * HIV-1 and HIV-2 negative * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior allogeneic peripheral blood stem cell or bone marrow transplantation * No planned future autologous transplantation unless sufficient stored stem cells available * Prior interferon allowed if administered as maintenance of stable plateau phase * No concurrent epoetin alfa Chemotherapy: * At least 3 months since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Concurrent radiotherapy for pain or to treat localized tumors allowed Surgery: * Not specified Other: * No prior participation in any clinical trial with an unlicensed product

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

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, England, W12 ONN, United Kingdom

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

CyclophosphamideDexamethasoneIdarubicinLomustineMelphalanPrednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicAminoglycosidesGlycosidesCarbohydratesNitrosourea CompoundsUreaAmidesNitroso CompoundsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Diana Samson, MD

    Hammersmith Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1998

Last Updated

September 20, 2013

Record last verified: 2001-02

Locations

GB(1)