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

NCT00396045 | Completed Phase 1

• 2 other identifiers: RV-MM-PI-026MPR
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 9

Brief 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. This association might further increase the response rate achieved by the standard oral MP regimen.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Lenalidomide, elderly patients

Outcome Measures

Primary Outcomes (1)

• SAFETY AND EFFICACY

Secondary Outcomes (1)

• PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Interventions

Revlimid (CC-5013) DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (9)

Unità Operativa di Ematologia, Spedali Civili

Brescia, Brescia, 25100, Italy

Location

Reparto di Ematologia, Ospedale Ferrarotto

Catania, Catania, 95124, Italy

Location

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

Cosenza, COSENZA, Italy

Location

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

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Clinica Ematologica, Ospedale San Martino -Università di Genova

Genova, Genova, 16132, Italy

Location

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

Parma, Parma, 43100, Italy

Location

Divisione di Ematologia-Policlinico Umberto I-Università La Sapienza

Roma, Roma, 00161, Italy

Location

Divisione di Ematologia, Azienda Ospedaliera Senese Ospedale A. Sclavo

Siena, Siena, 53100, Italy

Location

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

Torino, TORINO, 10126, Italy

Location

Related Publications (5)

• 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.

  PMID: 16116606 BACKGROUND

• 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.

  PMID: 14645435 BACKGROUND

• 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.

  PMID: 12384400 BACKGROUND

• 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.

  PMID: 9469346 BACKGROUND

• 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.

  PMID: 9753033 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• MARIO BOCCADORO, MD

  DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

  PRINCIPAL INVESTIGATOR

• ANTONIO PALUMBO, MD

  DIVISIONE UNIVERSITARIA DI EMATOLOGIA, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: January 1, 2005
• Study Completion: January 1, 2008
• Last Updated: November 30, 2006

Record last verified: 2006-11

Locations

IT (9)