Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients

NCT01160107 | Completed Phase 2 DMC

• 2 other identifiers: RV-MM-PI-3022007-007616-28
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

Conditions

Multiple Myeloma

Keywords

Diagnosis; Elderly Patients; Imids; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR)

  Determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.

  Approximately 24 months

Secondary Outcomes (1)

• Determine the progression free survival (PFS), overall survival (OS) and whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.

  Approximately 24 months

Study Arms (1)

RP followed MPR

EXPERIMENTAL

Drug: RP followed by MPR

Interventions

RP followed by MPR DRUG

Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%; 2. The study stop (if PR \<40% and grade 3-4 adverse events \>25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are \< 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are \> 50% and PR rate \> 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.

Also known as: Revlimid, Prednisone, Melphalan

RP followed MPR

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient is 65 years of age or older at the time of signing the informed consent.
• 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.
• 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 lenalidomide therapy.
• 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 lenalidomide therapy.
• Patient was a newly diagnosed multiple myeloma based on standard criteria
• Patient has measurable disease, defined as follows: - Secretory myeloma: 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; - Non-secretory myeloma: \> 30% plasma cells in the bone marrow and at least one plasmacytoma \> 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
• Patient has a Karnofsky performance status ≥ 50%.
• Patient has a life-expectancy \>3 months.

You may not qualify if:

• Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
• Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; \< to the equivalent of dexamethasone 40 mg/day for 4 days).
• Pregnant or lactating females
• Known positive for HIV or active infectious hepatitis type A, B or C

Sponsors & Collaborators

• Fondazione EMN Italy Onlus: lead

MeSH Terms

Conditions

Multiple Myeloma; Disease

Interventions

Lenalidomide; Prednisone; Melphalan

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mario Boccadoro, MD

  S.C. Ematologia U - AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: December 22, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06