Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Treatments

Drug: lenalidomide

Drug: cyclophosphamide

Drug: dexamethasone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00478218

P30CA015083 (U.S. NIH Grant/Contract)

RV-MM-PI-0116 (Other Identifier)

MC058E (Other Identifier)

06-002786 (Other Identifier)

CDR0000546657

Details and patient eligibility

About

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Full description

OBJECTIVES:

Primary

* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

Assess the toxicity of this regimen in these patients.
Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma
- Newly diagnosed disease
- Symptomatic disease
Measurable or evaluable disease, defined by ≥ 1 of the following criteria:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- Monoclonal protein > 200 mg by 24-hour urine electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
- Measurable soft tissue plasmacytoma not previously irradiated
No monoclonal gammopathy of undetermined significance or smoldering myeloma

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
ANC ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 8.0 g/dL
Creatinine ≤ 2.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy
No uncontrolled infection
No other active malignancy
No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
No NYHA class III-IV congestive heart failure
No untreated active deep vein thrombosis

PRIOR CONCURRENT THERAPY:

At least 3 weeks since prior radiotherapy for solitary plasmacytoma
Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed
No prior cytotoxic chemotherapy
No prior corticosteroids (except for treatment of a nonmalignant disorder)
Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed
No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture