Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: lenalidomide (Drug); melphalan (Drug); prednisone (Drug); chemotherapy (Procedure); steroid therapy (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Vivek Roy, MD, FACP, Study Chair, Affiliation: Mayo Clinic
Philip R. Greipp, MD, Affiliation: Mayo Clinic
Craig B. Reeder, MD, Affiliation: Mayo Clinic Scottsdale
Angela Dispenzieri, MD, Affiliation: Mayo Clinic
Rafael Fonseca, MD, Affiliation: Mayo Clinic Scottsdale
Morie A. Gertz, MD, Affiliation: Mayo Clinic
Martha Q. Lacy, MD, Affiliation: Mayo Clinic
John A. Lust, MD, PhD, Affiliation: Mayo Clinic
S. V. Rajkumar, MD, Affiliation: Mayo Clinic
Thomas E. Witzig, MD, Affiliation: Mayo Clinic
Steve Zeldenrust, MD, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant
Study design: Treatment
Primary outcome: Dose-limiting toxicities (Phase I)Confirmed response (Phase II)
Secondary outcome: Time to progression (Phase II)Overall survival (Phase II) Duration of response (Phase II) Toxicity as measured by NCI CTCAE v 3.0 (Phase II)
Detailed description:
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of melphalan and lenalidomide in combination with
prednisone in patients with newly diagnosed multiple myeloma.
- Determine the response rate in patients treated with this regimen.
Secondary
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II
study.
- Phase I: Patients receive oral melphalan and oral prednisone daily on days 1-4. Patients
also receive oral lenalidomide daily on days 1-21. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive oral melphalan and oral lenalidomide as in phase I at the
MTD. Patients also receive oral prednisone as in phase I. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259-5499, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2005
Last updated: February 28, 2008
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