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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Grupo de Estudos Multicentricos em Onco-Hematologia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier:
NCT01532856
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide, Cyclophosphamide, Dexamethasone
Drug: Thalidomide, Dexamethasone
Drug: Thalidomide, Melphalan, Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Grupo de Estudos Multicentricos em Onco-Hematologia:

Primary Outcome Measures:
  • Response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Response rate is evaluated between the 3 treatment arms

  • Duration of response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Duration of response was defined as the time to the first evidence of laboratorisl progreesion.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the interval from randomization to death or the last follow-up for surviving patients.

  • event-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Event-free survival was defined as the interval from randomization to any event (death or descontinuation due to protocol violation or non-acceptable toxicities)

  • progression free-survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Progression free-survival was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.


Enrollment: 64
Study Start Date: January 2007
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532856

Locations
Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil
Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Grupo de Estudos Multicentricos em Onco-Hematologia
Investigators
Principal Investigator: Vania Hungria, PhD MD Santa Casa de Misericordia de São Paulo
  More Information

No publications provided

Responsible Party: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier: NCT01532856     History of Changes
Other Study ID Numbers: GBRAM0002
Study First Received: February 10, 2012
Last Updated: February 14, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Grupo de Estudos Multicentricos em Onco-Hematologia:
multiple myeloma
thalidomide
comparative
elderly

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Melphalan
Prednisone
Thalidomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents

ClinicalTrials.gov processed this record on November 25, 2014