NCT00017602

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of dexamethasone by making cancer cells more sensitive to the drug. It is not yet known if dexamethasone is more effective with or without oblimersen in treating multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with or without oblimersen in treating patients who have relapsed or refractory multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 6, 2014

Status Verified

August 1, 2003

First QC Date

June 6, 2001

Last Update Submit

January 3, 2014

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Interventions

oblimersen sodiumBIOLOGICAL
dexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: NOTE: This trial is being conducted at many institutions throughout the country. Please contact Genta for a site near you. * Progressive multiple myeloma defined by one of the following: * Primary resistance or progressive disease after achieving less than a partial response after at least 2 courses of combination chemotherapy (that included at least 1 myelosuppressive drug) within the past 3 months * Relapsed or progressive disease after at least a partial response to prior therapy * Progressive disease after high-dose chemotherapy and autologous stem cell transplantation * Progressive disease defined by at least 1 of the following: * Increase in serum M-protein by at least 50% or at least 2 g/dL above the lowest remission or baseline level * Increase in urinary M-protein by at least 50% or at least 2 g/24 hours above lowest remission or baseline level * Appearance of new lytic bone lesions or at least 50% increase in size of an existing bone lesion * Quantifiable serum and/or urine paraprotein * Bone marrow plasmacytosis at least 5% of total nucleated cells * Measurable disease * Serum M-protein level at least 1.0 g/dL OR * Urinary M-protein excretion at least 200 mg/24 hours PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 50,000/mm3 * No bleeding or coagulation disorder Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * PT and PTT no greater than 1.5 times ULN * No history of chronic hepatitis or cirrhosis Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active symptoms of coronary artery disease (e.g., uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication) * No New York Heart Association class III or IV heart disease * No uncontrolled congestive heart failure * No grade 2 or greater cardiovascular signs or symptoms within the past 4 weeks Other: * HIV negative * No active peptic ulcer disease * No uncontrolled seizure disorder * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No active uncontrolled infection * No active autoimmune disease * No hypersensitivity to phosphorothioate-containing oligonucleotides or to dexamethasone * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 3 weeks since prior immunotherapy * At least 72 hours since prior thalidomide * Concurrent epoetin alfa allowed Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) Endocrine therapy: * At least 3 weeks since prior corticosteroids * No concurrent chronic corticosteroids Radiotherapy: * At least 14 days since prior radiotherapy except limited radiotherapy to a single bone lesion Surgery: * At least 3 weeks since prior major surgery * No prior organ allograft Other: * At least 4 weeks since other prior investigational therapy * No more than 6 prior therapies for myeloma * No concurrent immunosuppressive therapy

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

Sponsors & Collaborators

Study Sites (1)

Genta Incorporated

Berkeley Heights, New Jersey, 07922, United States

Location

Related Publications (1)

  • Chanan-Khan AA, Niesvizky R, Hohl RJ, Zimmerman TM, Christiansen NP, Schiller GJ, Callander N, Lister J, Oken M, Jagannath S. Phase III randomised study of dexamethasone with or without oblimersen sodium for patients with advanced multiple myeloma. Leuk Lymphoma. 2009 Apr;50(4):559-65. doi: 10.1080/10428190902748971.

    PMID: 19373653RESULT

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

oblimersenDexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Stanley R. Frankel, MD

    Genta Incorporated

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Study Completion

April 1, 2009

Last Updated

January 6, 2014

Record last verified: 2003-08

Locations

US(1)