Randomized Phase III Study of Dexamethasone With or Without Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

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