Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years

NCT01532856 | Unknown Phase 3 DMC

• 1 other identifier: GBRAM0002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

This protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is also designed to compare the safety and efficacy (in terms of duration of response) of two maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment arm will include 100 patients and assessments and scheduled visits will be conducted in three periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring all adverse events, physical examination, vital signs and biochemical studies. Response to treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles of induction therapy and monthly during the first year of maintenance therapy and every 3 months thereafter.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; thalidomide; comparative; elderly

Outcome Measures

Primary Outcomes (2)

• Response rate

  Response rate is evaluated between the 3 treatment arms

  36 months

• Duration of response

  Duration of response was defined as the time to the first evidence of laboratorisl progreesion.

  36 months

Secondary Outcomes (3)

• overall survival

  36 months

• event-free survival

  36 months

• progression free-survival

  36 months

Study Arms (3)

Group A induction therapy

ACTIVE COMPARATOR

Thalidomide + Cyclophosphamide + Dexamethasone

Drug: Thalidomide, Cyclophosphamide, Dexamethasone

Group B induction therapy

ACTIVE COMPARATOR

thalidomide + dexamethasone

Drug: Thalidomide, Dexamethasone

Group C induction therapy

ACTIVE COMPARATOR

thalidomide + melphalan + prednisone

Drug: Thalidomide, Melphalan, Prednisone

Interventions

Thalidomide, Cyclophosphamide, Dexamethasone DRUG

Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Cyclophosphamide - 50mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally(two pulses the first two cycles in days 1-4 and 15-18 and then a single pulse in each other cycle) during 9 cycles of 28 days.

Group A induction therapy

Thalidomide, Dexamethasone DRUG

Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally, in three pulses (days 1 to 4, 9 to 12 and 17 20) odd cycles and a single pulse treatment in pairs cycles, during 9 cycles of 28 days each cycle

Group B induction therapy

Thalidomide, Melphalan, Prednisone DRUG

thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle; melphalan - 4 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle; prednisone - 40 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle

Group C induction therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 65 years old and non candidate for autologous stem cell transplant
• Patient must be newly diagnosed with Multiple Myeloma according to establish criteria symptoms. Steroid pulses administration are allowed for any required emergency prior to starting induction therapy or bisphosphonates administration
• Patient must have measurable disease, defined as follows: for secretory multiple myeloma, measurable disease is defined by the presence of measurable monoclonal component in serum or in urine excretion if light chain is greater than or equal to 200 mg/24 hours(Annex 5)
• Measured ECOG \< 2 state level.
• The patient must have a life expectancy greater than 3 months.
• Adequate laboratory values prior to induction treatment initiation, defined as follow:
• Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g / dl and absolute neutrophil count ≥ 1000/mm3. Lower values are permitted if they are due to BM infiltration.
• Corrected serum calcium ≤ 14mg/dl.
• Aspartate transaminase (AST): ≤ 2.5 x normal upper limit.
• Alanine transaminase (ALT):): ≤ 2.5 x normal upper limit.
• Total bilirubin: ≤ 1.5 x normal upper limit.
• Serum creatinine ≤ 2 mg / dl.
• Men (including vasectomy done) must use barrier contraception (latex condoms) when having sex with women of potential childbearing, and for at least four weeks after thalidomide last dose.

You may not qualify if:

• Non-secretory MM.
• Previous treatment for multiple myeloma with the exception of steroid pulses for any emergency that requires treatment before beginning the induction, administration of bisphosphonates or radiation therapy.
• Known thalidomide hypersensitivity.
• Known human immunodeficiency virus(HIV) infection, detectable surface antigen of hepatitis B or active infection by the hepatitis C viruses
• Participation in another clinical trial or receiving any investigational agent.

Sponsors & Collaborators

• Grupo de Estudos Multicentricos em Onco-Hematologia: lead

Study Sites (3)

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Cyclophosphamide; Dexamethasone; Melphalan; Prednisone

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols

Study Officials

• Vania Hungria, PhD MD

  Santa Casa de Misericordia de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: January 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

BR (3)