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

February 14, 2012 updated by: Grupo de Estudos Multicentricos em Onco-Hematologia

Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maintenance Therapy With Thalidomide + Prednisone Versus Thalidomide Alone in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65years.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Hospital Universitario Clementino Fraga Filho
      • São Paulo, Brazil
        • Santa Casa de Misericordia de Sao Paulo
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Universidade Federal do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 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:

    1. 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.
    2. Corrected serum calcium ≤ 14mg/dl.
    3. Aspartate transaminase (AST): ≤ 2.5 x normal upper limit.
    4. Alanine transaminase (ALT):): ≤ 2.5 x normal upper limit.
    5. Total bilirubin: ≤ 1.5 x normal upper limit.
    6. 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.

Exclusion Criteria:

  • 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.
  • Basal peripheral neuropathy higher than grade 2 within 14 days of inclusion.
  • Known thalidomide hypersensitivity.
  • Use of any investigational agent within 30 days prior to their inclusion.
  • Known human immunodeficiency virus(HIV) infection, detectable surface antigen of hepatitis B or active infection by the hepatitis C viruses
  • Myocardial infarction within 6 months prior to inclusion or heart functional class III or IV according to New York Heart Association (NYHA) heart failure, angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram or conduction system abnormalities.
  • Participation in another clinical trial or receiving any investigational agent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A induction therapy
Thalidomide + Cyclophosphamide + Dexamethasone
Drug: Thalidomide, Cyclophosphamide, Dexamethasone
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.
ACTIVE_COMPARATOR: Group B induction therapy
thalidomide + dexamethasone
Drug: Thalidomide, Dexamethasone
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
ACTIVE_COMPARATOR: Group C induction therapy
thalidomide + melphalan + prednisone
Drug: Thalidomide, Melphalan, Prednisone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 36 months
Response rate is evaluated between the 3 treatment arms
36 months
Duration of response
Time Frame: 36 months
Duration of response was defined as the time to the first evidence of laboratorisl progreesion.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 36 months
Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.
36 months
event-free survival
Time Frame: 36 months
Event-free survival was defined as the interval from randomization to any event (death or descontinuation due to protocol violation or non-acceptable toxicities)
36 months
progression free-survival
Time Frame: 36 months
Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Estudos Multicentricos em Onco-Hematologia

Investigators

  • Principal Investigator: Vania Hungria, PhD MD, Santa Casa de Misericordia de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (ESTIMATE)

February 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBRAM0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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