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Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma


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

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Trial Information

Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma


OBJECTIVES:

- Compare the progression-free survival of patients with previously untreated stage I,
II, or III multiple myeloma treated with dexamethasone with or without lenalidomide.

- Compare the overall response rate in patients treated with these regimens.

- Compare the major response rate (indicated by greater than 75% decrease in M-protein)
in patients treated with these regimens.

- Compare the overall survival and time to best response in patients treated with these
regimens.

- Compare the toxicity profile of these regimens, including thrombotic complications, in
these patients.

- Compare the effect of these regimens on gene expression and proteomic analysis in these
patients.

OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are
stratified according to disease stage by the International Staging System (I vs II vs III)
and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment
arms.

Arm I

- Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and
17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3
courses in the absence of disease progression or unacceptable toxicity.

- Maintenance therapy: Patients receive oral DM on days 1-4 and 15-18 and oral
lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

Arm II

- Induction therapy: Patients receive DM as in arm I induction and oral placebo on days
1-28. Treatment repeats as in arm I induction.

Patients with responding or stable disease proceed to maintenance therapy. Patients with
disease progression during induction therapy cross over and receive unblinded treatment with
DM and lenalidomide as in arm I induction. Patients with responding or stable disease after
unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide
as in arm I maintenance.

- Maintenance therapy: Patients receive oral DM as in arm I maintenance and oral placebo
on days 1-21. Courses repeat as in arm I maintenance.

Patients with disease progression during maintenance therapy cross over and receive
unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding
or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy
with DM and lenalidomide as in arm I maintenance.

Patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Previously untreated multiple myeloma

- Stage I, II, or III disease by the International Staging System

- Measurable M-protein as defined by 1 of the following:

- Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or
immunoelectrophoresis

- Urinary M-protein excretion at least 200 mg/24 hours

- No nonsecretory multiple myeloma

- Not planning to undergo future autologous stem cell transplantation

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of
disability

Life expectancy

- Not specified

Hematopoietic

- Platelet count at least 80,000/mm^3*

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

- Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due
to greater than 50% marrow involvement by myeloma on biopsy

Hepatic

- AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this
range are allowed at the investigator's discretion

Renal

- Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed
at the investigator's discretion

Cardiovascular

- No New York Heart Association class III or IV heart failure

- No myocardial infarction within the past 6 months

- No poorly controlled hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 4 weeks before, during, and for
4 weeks after study treatment

- Female patients must use 2 reliable forms of contraception simultaneously

- Male patients must use effective barrier contraception

- No uncontrolled active infection requiring IV antibiotics

- No poorly controlled diabetes mellitus that would preclude ability to take oral
glucocorticoids

- No other serious medical condition that would preclude study participation

- No psychiatric illness that would preclude study participation

- No other malignancy within the past 3 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin
subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except
if already on therapeutic anticoagulant medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior interferon or thalidomide

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior high-dose dexamethasone allowed provided duration of administration was no more
than 4 days

Radiotherapy

- Prior localized radiotherapy allowed provided it was not to the sole site of
evaluable disease

Surgery

- Not specified

Other

- No prior treatment for clinically significant ventricular cardiac arrhythmias

- Concurrent bisphosphonates allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Jeffrey A. Zonder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000306449

NCT ID:

NCT00064038

Start Date:

November 2004

Completion Date:

Related Keywords:

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

Name

Location

William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106