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A Multicenter, Open Label Study of Oral Melphalan, Prednisone, and CC-5013 (Revlimid) (MPR) as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients

Phase 1/Phase 2
65 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Multicenter, Open Label Study of Oral Melphalan, Prednisone, and CC-5013 (Revlimid) (MPR) as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients

In Multiple Myeloma patients, the standard treatment is the oral combination of Melphalan
and Prednisone (MP). This approach induces a partial response (PR) rate of approximately 50%
and a complete remission (CR) rate of 1-5%, with a median remission duration of 18-20
months and a median overall survival of 3 years.

Recently, the combination of oral MP plus thalidomide increased response rate to 80% and
complete remission rate to 20%, marked cytoreduction is the first step toward a sustained
remission period.

CC-5013 (Revlimid) is a thalidomide analogue, 50000 times more potent than thalidomide in
inhibiting TNF-alfa secretion, a potent growth factor for myeloma cells. Revlimid represents
a novel class of anti-cancer drugs, it is active in patients with multiple myeloma who are
refractory to conventional and high-dose chemotherapy with a response rate of approximately
30%. The association Revlimid plus dexamethasone further increases the response rate induced
by Revlimid by an additional 30%.

This study will evaluate the safety and efficacy of the association of
Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma
patients over age 65 or those under 65 years who refuse or are not eligible for high dose
therapy. This association might further increase the response rate achieved by the standard
oral MP regimen.

In the first part of the study (phase I component), different doses of oral Melphalan
(0.18-0.25 mg/Kg) associated with Prednisone (MP) will be combined with escalating doses of
Revlimid (from 5 mg/day) and administered together. This phase will define the MTD of the
association. In the second part of the study (phase II component), 30 patients will be
treated with MPR at dose/s defined from phase I component to verify data of response and

Inclusion Criteria:

- Patient is of a legally consenting age as defined by local regulations.

- Age > 65 years or age < 65 years in patients who refuse or are not eligible for
high-dose therapy.

- Patient is, in the investigator(s) opinion willing and able to comply with the
protocol requirements.

- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their future
medical care.

- Female patient is either post-menopausal for 24 consecutive months or surgically
sterilised or agree to continuous abstinence from heterosexual sexual contact or
willing to use two acceptable method of birth control at the same time (one highly
effective method and one additional effective method)(Highly Effective Methods:
Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-;
tubal ligation; partner’s vasectomy; Additional Effective Methods: Latex condom;
Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during
study drug therapy (including dose interruption) and for 4 weeks after
discontinuation of Lenalomide therapy - Male patient agrees to use an acceptable
method for contraception (i.e., condom or abstinence) during study drug therapy
(including dose interruption) and for 4 weeks after discontinuation of Lenalomide

- Patient was previously diagnosed with symptomatic multiple myeloma based on standard
criteria, and has measurable disease, defined as follows: any quantifiable serum
monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG
M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine
light-chain excretion of >200 mg/24 hours; measurable plasmacytoma as determined by
clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow
plasma cells >10%.

- Patient has a Karnofsky performance status ≥ 60%

- Patient has a life-expectancy > 6 months.

- Patient has the following laboratory values within 14 days before Baseline
(day 1 of the Cycle 1):

- Absolute neutrophil count > 1.5 x 109/L without the use of growth factors

- Platelet count > 75 x 109/L without transfusion support within 7 days before the

- Calculated or measured creatinine clearance: ≥ 20 mL/minute

- Total bilirubin < 1.5 x the ULN

- AST (SGOT) and ALT (SGPT) < 2.5 x ULN

- Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

- Pregnant or beast feeding females.

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

- Use of any other concomitant standard/experimental anti-myeloma drug or therapy.

- Any prior use of CC-5013 or other anti-myeloma therapy.

- Any of the following laboratory abnormalities:

- Platelet count < 75 x 109/L.

- Absolute neutrophil count <1.5 x 109/L.

- Calculated or measured creatinine clearance <20 mL/minute.

- Corrected serum calcium >14 mg/dL (3.5 mmol/L).

- Aspartate transaminase (AST): >2.5 x the upper limit of normal (ULN).

- Alanine transaminase (AST): > 2.5 x the ULN.

- Total bilirubin: > 1.5 x the ULN.

- Known positive for HIV or active infectious hepatitis, type B or C.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



Italy: Ministry of Health

Study ID:




Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma, Lenalidomide, elderly patients
  • Multiple Myeloma
  • Neoplasms, Plasma Cell