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An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Phase 3
18 Years
Open (Enrolling)
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy


I. To compare progression-free survival between patients receiving melphalan, prednisone,
and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple
myeloma patients who are not candidates for high-dose therapy.


I. To compare overall survival between both arms. II. To compare response rates and depth of
response in these patients. III. To compare the incidence of toxicities in these patients.
IV. To validate the TC classification of myeloma as a prognostic tool using gene expression
profiling at diagnosis.


I. To compare quality-of-life (QOL) change between arms based on the FACT-Ntx TOI from
baseline to the end of course 24 (maintenance therapy).

II. To examine the impact of differential treatment responses on QOL based on the FACT-Ntx
TOI up to course 38.

III. To obtain prospective data on myeloma specific QOL attributes.

OUTLINE: This is a multicenter study. Patients are stratified according to ISS stage (I-II
vs III) and age (< 65 vs ≥ 65). Patients are randomized to 1 of 2 treatment arms.


INDUCTION THERAPY: Patients receive oral melphalan and oral prednisone once daily on days
1-4, and oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive oral thalidomide once daily and continue in the
absence of disease progression.


INDUCTION THERAPY: Patients receive oral melphalan and oral prednisone once daily on days
1-4, and oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive oral lenalidomide once daily on days 1-21. Treatment
repeats every 28 days in the absence of disease progression.

Quality of life is assessed at baseline and periodically during treatment.

Peripheral blood and bone marrow samples are collected at baseline for gene expression
profiling analysis.

After completion of study treatment, patients will be followed periodically for 10 years.

Inclusion Criteria:

- Newly diagnosed multiple myeloma (MM), meeting the following criteria:

- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or
biopsy proven plasmacytoma

- Symptomatic disease with evidence of end-organ damage at initial diagnosis that
prompted the initiation of therapy, including ≥ 1 of the following:

- Anemia

- Hypercalcemia

- Bone disease (lytic bone lesions or pathologic fracture)

- Renal dysfunction

- No smoldering MM, defined by all of the following:

- Serum monoclonal protein ≥ 3 g/dL

- Bone marrow plasma cells ≥ 10% or greater

- Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction

- No monoclonal gammopathy of undetermined significance, defined by all of the

- Serum monoclonal protein < 3 g/dL

- Bone marrow plasma cells ≤ 10%

- Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction

- Previously untreated for MM

- Patients 18 to 64 years old must not be a candidate for autologous stem cell
transplantation or have declined transplantation or other alternative treatment

- ECOG performance status 0-2

- Hemoglobin > 7 g/dL

- Platelet count > 75,000/mm³

- ANC > 1,000/mm³

- Creatinine < 2.5 mg/dL AND creatinine clearance (measured or calculated) ≥ 60 mL/min

- Direct bilirubin ≤ 1.5 mg/dL

- ALT and AST ≤ 2.5 times upper limit of normal

- No uncontrolled intercurrent illness that would limit compliance with the study
including, but not limited to, any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation

- Prior history of Stevens Johnson syndrome

- No peripheral neuropathy ≥ grade 2

- No active uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-barrier contraception 4 weeks prior to,
during, and 4 weeks after completion of study treatment

- Must be able to take prophylactic aspirin 325mg/day or low-molecular weight heparin
or Coumadin

- No second active malignancy requiring treatment within the past 2 years, except for
basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix

- Concurrent localized radiation therapy is allowed for pain control at the physician's

- No prior treatment for myeloma except for either of the following:

- Prednisone or dexamethasone treatment for myeloma for a duration of less than 4

- Prednisone or dexamethasone in combination with thalidomide or lenalidomide for
a duration of less than 2 weeks total

- Concurrent bisphosphonates or growth factors (i.e., erythropoietin) for MM allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Tested using one-sided 0.95 confidence limits.

Outcome Time Frame:

From randomization to the earlier of progression or death of any cause, assessed up to 10 years

Safety Issue:


Principal Investigator

Alexander Stewart

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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