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Multiple MyelomaPhase 1/2NCT00396045

Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma

A Phase 1/2 study testing Revlimid (CC-5013) in people with Multiple Myeloma, run by University of Turin, Italy at 9 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Revlimid (CC-5013)
How many people
54 participants
Where
9 sitesItaly
Study dates
Jan 2005to Jan 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 therapy.
  • 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%.
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  • 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 test.
  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • Unità Operativa di Ematologia, Spedali Civili

    Brescia, Brescia, 25100

  • Reparto di Ematologia, Ospedale Ferrarotto

    Catania, Catania, 95124

  • Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza

    Cosenza, COSENZA

  • Clinica Ematologica, Ospedale San Martino -Università di Genova

    Genova, Genova, 16132

  • Cattedra di Ematologia, Dipart. Di Medicina Interna e Scienze Biomediche

    Parma, Parma, 43100

  • Divisione di Ematologia-Policlinico Umberto I-Università La Sapienza

    Roma, Roma, 00161

  • Unità Operativa di Ematologia Trapianto di Cellule Staminali, Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Divisione di Ematologia, Azienda Ospedaliera Senese Ospedale A. Sclavo

    Siena, Siena, 53100

  • Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista

    Torino, TORINO, 10126

Other trials in Italy

About this study

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

The purpose of this study is to 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.

Read the detailed description

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 toxicity.

Being tested
Revlimid (CC-5013)
Keywords
Multiple Myeloma, Lenalidomide, elderly patients
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Revlimid (CC-5013)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAFETY AND EFFICACY

Secondary outcomes (1)

  1. PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2006 (estimated)
  2. Study startJan 2005
  3. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00396045
Sponsor's protocol ID
RV-MM-PI-026
Other IDs
MPR
Status last verified
Nov 2006
First submitted
2 Nov 2006
Last updated
30 Nov 2006
Results posted
No

Publications

  • Palumbo A, Bertola A, Musto P, Caravita T, Callea V, Nunzi M, Grasso M, Falco P, Cangialosi C, Boccadoro M. Oral melphalan, prednisone, and thalidomide for newly diagnosed patients with myeloma. Cancer. 2005 Oct 1;104(7):1428-33. doi: 10.1002/cncr.21342.

    PubMed 16116606

  • Dimopoulos MA, Anagnostopoulos A, Weber D. Treatment of plasma cell dyscrasias with thalidomide and its derivatives. J Clin Oncol. 2003 Dec 1;21(23):4444-54. doi: 10.1200/JCO.2003.07.200.

    PubMed 14645435

  • Richardson PG, Schlossman RL, Weller E, Hideshima T, Mitsiades C, Davies F, LeBlanc R, Catley LP, Doss D, Kelly K, McKenney M, Mechlowicz J, Freeman A, Deocampo R, Rich R, Ryoo JJ, Chauhan D, Balinski K, Zeldis J, Anderson KC. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood. 2002 Nov 1;100(9):3063-7. doi: 10.1182/blood-2002-03-0996.

    PubMed 12384400

  • Kraut EH, Crowley JJ, Wade JL, Laufman LR, Alsina M, Taylor SA, Salmon SE. Evaluation of topotecan in resistant and relapsing multiple myeloma: a Southwest Oncology Group study. J Clin Oncol. 1998 Feb;16(2):589-92. doi: 10.1200/JCO.1998.16.2.589.

    PubMed 9469346

  • Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.

    PubMed 9753033

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Revlimid (CC-5013) in people with Multiple Myeloma, run by University of Turin, Italy at 9 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAFETY AND EFFICACY. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00396045, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2006; AzTrials last refreshed its copy on 6 Nov 2026.

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