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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


OBJECTIVES:

- Compare the time to disease progression in patients with relapsed or refractory
multiple myeloma treated with dexamethasone with or without oblimersen.

- Compare the duration of response and objective response rate in patients treated with
these regimens.

- Compare the proportion of patients without disease progression after 6 months and the
proportion of patients who have not discontinued treatment after 6 months in these two
patient groups.

- Compare the safety of these regimens in these patients.

- Compare survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to response to prior therapy (relapsed vs refractory), prior autologous stem cell
transplantation (yes vs no), and number of prior therapy regimens (1-2 vs 3-6). Patients are
randomized to 1 of 2 treatment arms.

Arm I

- Induction: Patients receive oblimersen (G3139) IV continuously on days 1-7 and 15-21
and oral dexamethasone daily on days 4-7, 11-14, and 18-21.

- Maintenance: One week after completion of induction therapy, patients with stable or
responsive disease receive G3139 IV continuously on days 1-7 and oral dexamethasone
daily on days 4-7. Courses repeat every 3 weeks for a maximum of 1 year in the absence
of disease progression or unacceptable toxicity.

Arm II

- Induction: Patients receive oral dexamethasone daily for 4 days on weeks 1-3.

- Maintenance: One week after completion of induction therapy, patients with stable or
responsive disease receive oral dexamethasone daily for 4 days. Courses repeat every 3
weeks for a maximum of 1 year in the absence of disease progression or unacceptable
toxicity.

Patients are followed every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stanley R. Frankel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Genta Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000068722

NCT ID:

NCT00017602

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Genta IncorporatedBerkeley Heights, New Jersey  07922