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A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma


OBJECTIVES:

- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms
of complete and partial response rates, in patients with relapsed or refractory
multiple myeloma.

- Determine the time to progression and duration of response in patients treated with
this regimen.

- Determine the toxicity of this regimen in these patients.

- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients
treated with this regimen.

- Determine the disease-free and overall survival of patients treated with this regimen.

OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days
1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral
thalidomide daily beginning on day 4. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients with stable disease after induction therapy receive maintenance therapy comprising
oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide
daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression
or unacceptable toxicity.

Patients are followed for 3 years.

PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically and clinically confirmed multiple myeloma

- Relapsed and/or refractory after chemotherapy or transplantation

- Patients with prior allogeneic transplantation must not have evidence of
active graft-vs-host disease requiring immune suppression

- Measurable disease defined by quantitative immune globulin levels in serum and/or
urine and bone marrow plasmacytosis

- Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma
lesion is accurately measurable by MRI or CT scan

- No known CNS involvement

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count at least 1,000/mm^3*

- Platelet count at least 50,000/mm^3* NOTE: *Unless secondary to bone marrow
plasmacytosis (more than 80% involvement)

Hepatic

- Bilirubin less than 2 times normal

- AST/ALT no greater than 3 times upper limit of normal

Renal

- Creatinine no greater than 2 mg/dL

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Seizures allowed if under adequate control

- No severe skin reactions from prior thalidomide

- No prior allergic reactions attributed to agents used in this study

- No sensory or motor neuropathy grade II or greater

- No other uncontrolled concurrent illness that would preclude study therapy

- No ongoing or active infection

- No psychiatric illness or social situations that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception for 1 month before,
during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- See Chemotherapy

- At least 6 weeks since prior thalidomide

Chemotherapy

- See Disease Characteristics

- No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic
stem cell transplantation regimens

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

Endocrine therapy

- Concurrent continuous steroids allowed for chronic treatment of disorders other than
myeloma

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior oblimersen

- No other concurrent anticancer therapies or investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete and partial remission

Safety Issue:

No

Principal Investigator

Ashraf Z. Badros, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000258058

NCT ID:

NCT00049374

Start Date:

September 2002

Completion Date:

January 2006

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

St. Vincent's Comprehensive Cancer Center - ManhattanNew York, New York  10011
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201