InMuMyel I Study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Use of alpha interferon in the treatment of the maintenance phase of multiple myeloma.

Secondary indentifying numbers:

IG/INR/NM/9701

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB). Ministry of Public Health, CUBA.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

National Institute of Haematology and Immunology, Carlos Hernández Padrón MD. 2nd grade Specialist in Haematology. Clinical - Surgical Hospital "Hermanos Ameijeiras", Raúl de Castro Arenas MD. 2nd grade Specialist in Haematology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Military Hospital "Carlos J. Finlay", Ernesto Morales Pérez MD. 1st grade Specialist in Haematology. Havana, Clinical-Surgery Hospital "Joaquín Albarrán", Rebeca Rivas Pelegrin MD. 1st grade Specialist in Haematology. Havana, Clinical-Surgery Hospital "Salvador Allende", René Ortega González MD. 1st grade Specialist in Haematology. Havana, Universitary Hospital "Calixto García", Lorenzo Muñoz MD. 1st grade Specialist in Haematology. Havana, Institute of Military Medicine "Luis Díaz Soto", Margarita Morales Peralta MD. 1st grade Specialist in Haematology. Havana, Research Center Medical Surgical, Clara Luna Conde MD. 1st grade Specialist in Haematology. Havana, Clinical-Surgery Hospital "Comandante Manuel Fajardo", Carmen Virginia Diaz MD. 1st grade Specialist in Haematology. Sancti Spíritus, Provincial Hospital "Camilo Cienfuegos", Rolando Camacho MD. 1st grade Specialist in Haematology. Santiago de Cuba, General Hospital "Saturnino Lora", Jorge Lozada Gómez MD. 1st grade Specialist in Haematology. Granma, Provincial Hospital "Celia Sánchez", Julio Hechevarría MD. 1st grade Specialist in Haematology. Holguin, Provincial Hospital "Lucia Inniguez", Elia Ortiz MD. 1st grade Specialist in Haematology. Las Tunas, Provincial Hospital "Ernesto Guevara", Rogelio Pérez Rivero MD. 1st grade Specialist in Haematology. Ciego de Ávila, Provincial Hospital "Antonio Luaces", Mayra García Morales MD. 1st grade Specialist in Haematology. Villa Clara, Universitary Hospital "Arnaldo Milian Castro", Manuel Antonio Arce MD. 1st grade Specialist in Haematology. Villa Clara, Provincial Hospital "Celestino Hernández", Lourdes de la Rosa MD. 1st grade Specialist in Haematology. Cienfuegos, Provincial Clinical and Surgical Hospital "Gustavo Aldereguía", Julio Fernández MD. 1st grade Specialist in Haematology. Matanzas, Provincial Hospital "Jose R. López", Nereyda Álvarez Vega MD. 1st grade Specialist in Haematology. Pinar del Río, Provincial Hospital "Abel Santamaria", Maria Victoria López MD. 1st grade Specialist in Haematology.

Research ethics committees:

Centralized Ethics Committee and Review, September 19, 1998.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

30/09/1998

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Multiple Myeloma

Intervention(s):

It is followed by two treatment phases: an induction phase and a maintenance phase. Induction phase: administering any of the schemes used as induction therapy (M + P, VMCP, VAD or other preferably containing melphalan), in a period of not less than 6 months. Maintenance phase (after positive response): administering recombinant IFN-alpha 2b 3 million IU per square meter of body surface, intramuscularly, 3 times per week on alternate days for two years.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Proportion of patients with relapses (Yes, No). Measuring time: at 2 years of treatment.

Key secondary outcomes:

- Relapse-free interval (days, months, years). Measuring time: every 3 months to 2 years after initial treatment. - Number of relapses (numeric value). Measuring time: at 2 years of starting treatment. - Survival (alive, dead). Measuring time: at 2 years of starting treatment. - Hematological response (hemoglobin, hematocrit, white blood cell count with differential and platelet count). Measuring time: every 3 months to 2 years after initial treatment. - Proportion of patients developing adverse events (Yes, No). Measuring time: every 3 months to 2 years after initial treatment. - Proportion of patients who develop anti-IFN antibodies (Yes, No). Measuring time: every 3 months to 2 years after initial treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

N/A (No limit)

Inclusion criteria:

1) Patients over 18 years. 2) Willingness of the individual by signing written consent. 3) Patients with multiple myeloma stage II / III according to Salmon and Durie classification. 4) Patients who have received favorable response to chemotherapy with a minimum of 6 months of treatment.

Exclusion criteria:

1) Pregnancy or lactation. 2) Women of childbearing age who are hormonal contraceptive therapy or have no control over fertility. 3) Hypersensitivity to interferon or other preparations used in the study. 4) Acute or chronic liver (twice the normal value of TGP and TGO and / or total bilirubin > 1.5). 5) Decompensated heart failure. 6) Organic brain disease with symptoms that interfere with patient assessment so as to consent (eg Parkinson disease). 7) Major psychiatric disorder or other constraints that prevent the patient's consent. 8) Autoimmune diseases not related to multiple myeloma.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MSc. Yanelda

Middle Name:

de los Angeles

Last Name:

García Vega

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

yanelda.garcia@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

MSc. Yanelda

Middle Name:

de los Angeles

Last Name:

García Vega

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

yanelda.garcia@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000115

Date of Registration in Primary Registry:

2011-05-19

Record Verification Date:

2011-04-24 20:00

Link to the spanish version:

Click here [3]