Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	MAYO-MC038A MC038A, MAYO-IRB-2387-04, NCT00477750

Objectives

Primary

1. Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma.
2. Determine the response rate in patients treated with this regimen.

Secondary

1. Determine the toxicity of this regimen in these patients.

Entry 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%

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

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)

Expected Enrollment

Outcomes

Dose-limiting toxicities (Phase I)
Confirmed response (Phase II)

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)

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Vivek Roy, MD, FACP, Protocol chair		Ph: 507-538-7623 Email: roy.vivek@mayo.edu
Philip Greipp, MD, Protocol co-chair		Ph: 507-538-7623 Email: greipp.philip@mayo.edu
Craig B. Reeder, MD, Protocol co-chair		Ph: 507-538-7623
Angela Dispenzieri, MD, Protocol co-chair		Ph: 507-538-7623
Rafael Fonseca, MD, Protocol co-chair		Ph: 507-538-7623 Email: fonseca.rafael@mayo.edu
Morie Gertz, MD, Protocol co-chair		Ph: 507-538-7623
Martha Lacy, MD, Protocol co-chair		Ph: 507-538-7623 Email: lacy.martha@mayo.edu
John Lust, MD, PhD, Protocol co-chair		Ph: 507-538-7623 Email: lust.john@mayo.edu
S. Rajkumar, MD, Protocol co-chair		Ph: 507-538-7623 Email: rajkumar.vincent@mayo.edu
Thomas Witzig, MD, Protocol co-chair		Ph: 507-538-7623 Email: witzig.thomas@mayo.edu
Steve Zeldenrust, MD, Protocol co-chair		Ph: 507-538-7623

Registry Information
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
Trial Start Date		2005-06-06
Trial Completion Date		2016-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00477750
Date Submitted to PDQ		2007-04-27
Information Last Verified		2009-01-06
NCI Grant/Contract Number		CA15083

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