Phase 2 N=26 Treatment

Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT00477750 ↗

Enrolled (actual)

Serious AEs

26.9%

Results posted

Dec 2010

Primary outcome: Primary: Patients With Overall Confirmed Response — 3; 5; 10 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: lenalidomide (Drug); melphalan (Drug); prednisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With Overall Confirmed Response	3; 5; 10	—
SECONDARY Progression-free Survival	21.4	—
SECONDARY Overall Survival (OS) at 3 Years	58	—
SECONDARY Duration of Response (DOR)	16.3	—
SECONDARY Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)	33; 67; 0	—

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma
Newly diagnosed disease
Requires treatment, in the judgment of the treating physician
Not a candidate for (or patient declines) autologous stem cell transplantation
Meets 1 of the following criteria:
Measurable disease, defined by any of the following:
Serum monoclonal protein ≥ 1 g/dL
Urine protein monoclonal light chain ≥ 200 mg/24 hours by electrophoresis
Measurable serum free light chains ≥ 10 mg/dL, kappa or lambda, AND κ/λ ratio is abnormal (if serum and urine are not measurable as defined above)
Evaluable disease, defined as monoclonal bone marrow plasmacytosis ≥ 30%

PATIENT CHARACTERISTICS:

ECOG performance status 0-3
Life expectancy > 3 months
ANC ≥ 1,500/mm³
Bilirubin ≤ 2.0 mg/dL
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 3.0 mg/dL
Platelet count ≥ 100,000/mm³
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception, including ≥ 1 highly effective method, ≥ 4 weeks before and during study treatment
No uncontrolled infection
No peripheral neuropathy ≥ grade 2
No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance
No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
Prior malignancy allowed if treated with curative intent and is free of disease for a period appropriate for that cancer
No known hypersensitivity to thalidomide
No known HIV positivity
No infectious hepatitis A, B or C
No history of deep vein thrombosis or other medical condition requiring the use of warfarin
Able to take daily prophylactic acetylsalicylic acid (81 or 325 mg)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 4 weeks since prior radiotherapy for treatment of multiple myeloma
No prior lenalidomide
No other concurrent anticancer agents or treatments
No concurrent steroids except prednisone ≤ 20 mg/day (or the equivalent) for concurrent illness or adrenal replacement therapy
No other concurrent investigational therapy or agent for treatment of multiple myeloma
No concurrent warfarin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00477750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.