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A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction

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Trial Conditions
  • Multiple Myeloma and Plasma Cell Neoplasm
What is the purpose of this trial?

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying giving lenalidomide and dexamethasone together with bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Newly diagnosed multiple myeloma (MM)

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

- Measurable disease

- Nonsecretory MM based upon standard M-component criteria (i.e., measurable
serum/urine M-component) is not allowed unless the baseline serum free light chain
level (Freelite™) is elevated

- Serum Freelite must be drawn

- No freelite chains

- Must be offered participation in the Myeloma Specimen Repository for banking and
future research, and in the Gene Expression Profiling (GEP) molecular studies for the
evaluation of genetic polymorphisms

- Must have baseline skeletal survey, including lateral skull, anteroposterior (AP)
pelvis and posteroanterior (PA) chest within 28 days prior to study entry

- Institutions must submit a local cytogenetics report and FISH analysis prior to study
entry

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-3

- Platelet count ≥ 80,000/mm³*

- ANC ≥ 1,000/mm³*

- Hemoglobin ≥ 9.0 g/dL* (including patients who have been transfused or treated with
epoetin)

- Creatinine clearance > 30 cc/min

- FEV_1 and FVC ≥ 50% of predicted**

- DLCO ≥ 50% of predicted**

- No uncontrolled, active infection requiring IV antibiotics

- No NYHA class III-IV heart failure

- No myocardial infarction within the past 6 months

- No history of treatment for clinically significant ventricular cardiac arrhythmias

- No poorly controlled hypertension

- No poorly controlled diabetes mellitus

- No chronic obstructive or chronic restrictive pulmonary disease

- Must have undergone an EKG within the past month

- No psychiatric illness that could potentially interfere with the completion of study
treatment

- No history of cerebral vascular accident with persistent neurologic deficits

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years

- No hepatitis B or C positivity

- HIV negative***

- 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

- Patients with pathologic fractures, pneumonia at diagnosis, or symptomatic
hyperviscosity syndrome must have these conditions attended to prior to study entry
(i.e., intramedullary rod, IV antibiotics, or plasmapheresis)

- Patients must have baseline skeletal survey that include lateral skull,
anteroposterior (AP) pelvis, and posteroanterior (PA) chest within the past 28 days
NOTE: *Except patients with biopsy-proven heavy-marrow involvement, defined as having
≥ 30% marrow cellularity with > 50% of the cells being malignant plasma cells
(documented marrow results required)

NOTE: **Patients who are unable to complete pulmonary function tests due to bone pain or
fracture must undergo high resolution CT scan of the chest and have acceptable arterial
blood gases, defined as P02 > 70; these tests must be completed within 42 days prior to
study entry

NOTE: ***Patients with treatment-sensitive HIV infection are eligible provided
immunological and virologic indices are indicative of favorable long-term survival
prospects on the basis of HIV infection, but whose life expectancy is limited
predominantly by multiple myeloma rather than HIV infection in the judgement of the
treating physician

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy for this disease

- No prior radiotherapy to a large area of the pelvis (i.e., more than half of the
pelvis)

- No prior bortezomib or lenalidomide

- Prior steroid treatment allowed provided treatment was no more than 2 weeks in
duration

- Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg
subcutaneously daily if allergic to aspirin) as prophylactic coagulation

Gender: Both
Steward Physician(s)
  • Brian G. M. Durie, MD
  • Bart Barlogie, MD
Trial Interventions
Drug
  • bortezomib
  • dexamethasone
  • lenalidomide
Physician Researcher

Investigator Name:

  • Brian G. M. Durie, MD
  • Bart Barlogie, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00644228
Volunteers:  Not Accepting Healthy Volunteers

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