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Retrospective Viability Study of the PETHEMA-POMCIDEX Clinical Practice Guidelines for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma (RRMM)

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ClinicalTrials.gov Identifier: NCT03477643
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:

Multiple myeloma (MM) is a plasma cell neoplasm representing the second most common type of hematologic tumor after lymphomas. The incorporation of novel agents such as bortezomib, lenalidomide, or thalidomide into first-line treatment as well as in relapse settings has led to a significant improvement in survival rates for MM patients, which have doubled in the last 5-7 years (1,2). However, except for a small percentage of patients (10-30%)(3) that may achieve a cure after first-line treatment, in the majority of cases, MM behaves as an incurable disease whose clinical course is characterized by repeated relapses, shorter and shorter periods of remission, and by becoming refractory to succesive treatments (bortezomib or lenalidomide). In this situation, survival is generally less than 9 months, which underscores the need to develop new drugs for MM patients Pomalidomide, a third-generation immunomodulatory drug (IMiD), has demonstrated efficacy in patients with relapsed and refractory MM, with an overall response rate that fluctuates between 30-60% depending on whether it is administered in combination with low-dose dexamethasone or in association with treatment with a cytostatic agent such as cyclophosphamide.

In clinical trial CC-4047-MM-003, treatment with pomalidomide and low-dose dexamethasone in patients with relapsed and refractory MM or those intolerant to bortezomib or lenalidomide was a successful rescue treatment in 30% of patients with a median progression-free survival of 4 months. The association of cyclophosphamide at dose of 400mg/day on days 1, 8, and 15 of each cycle is able to increase the overall response rate from 39% for combination pomalidomide-dexamethasone to up to 65% for the triple regimen (pomalidomide, cyclophosphamide, dexamethasone - POMCIDEX), as well as the median PFS from 4.4 mo. to 9.2 mo. respectively. As well, the tolerance and safety profiles of the triple combination pomalidomide, cyclophosphamide, and dexamethasone were acceptable.

The association of bortezomib with pomalidomide-dexamethasone also increases the overall response rate (85%) and prolongs PFS (10.7 months).

The BiRD study (lenalidomide, dexamethasone, and clarithromycin) suggests that clarithromycin intensifies the effect of corticosteroids, increasing their anti-myeloma effect . A study evaluating the combination of clarithromycin with pomalidomide and low-dose dexamethasone in RRMM patients showed an overall response rate of 57% and clinical benefit rate (considered equal or superior to minor response) of 66%.

Since July 2014, pomalidomide (Imnovid®) in combination with dexamethasone has been approved for the treatment of adult patients with relapsed and refractory MM who have received at least two prior lines of therapy (including bortezomib and lenalidomide) and who have shown progressive disease to the last line of treatment.

In Spain in January of 2015, and in the Spanish Myeloma Group (GEM) context, we implemented clinical practice guidelines for the treatment of RRMM patients who are candidates for pomalidomide treatment with a triple therapy combination pomalidomide + cyclophosphamide + low-dose dexamethasone (POMCIDEX) (Appendix 1). The goal of the clinical practice guidelines was to increase the overall response rate, quality of response, and progression-free survival in patients treated with POMCIDEX. In patients with suboptimal response (defined as stable disease in the first 3 cycles, or inferior to partial response after six cycles according to International Myeloma Working Group Uniform Response Criteria [7]), clarithromycin can be added to their treatment at a dose of 500mg/12hrs on days 1-28 of each cycle. Treatment can be administered until disease progression, unacceptable toxicity, or based on patient decision.

Keeping in mind the time that has passed since the approval of pomalidomide for use in Spain and the publication of the clinical practice guidelines, we believe it is now time for a retrospective evaluation of the results of the therapeutic guidelines for Spanish MM patients and to review the viability of the recommendations contained in the guidelines with respect to compliance with the same, and effectiveness of the planned course of treatment. Once the viability of the proposed therapy regimen has been evaluated, other analyses for the purpose of studying the clinical results of treatment can be carried out as a separate analysis.

The therapeutic paradigm for MM is rapidly changing due to the availability of new drugs for the treatment of patients with refractory or relapsed disease, making clinical decisions more challenging. For this reason, the availability of data obtained from real-life settings, outside of clinical trials, is essential in order to choose the appropriate treatment for each patient


Condition or disease
Relapsed and Refractory Multiple Myeloma

Detailed Description:

This is a national, multicentre, observational, retrospective, open-label, non-randomized, non-interventional study to evaluate the degree of compliance at PETHEMA centres in Spain with the clinical practice guidelines proposed by the Spanish Myeloma Group for the treatment of relapsed and refractory MM with POMCIDEX.

In this study, all patients will be included retrospectively who met the inclusion criteria for the GEM clinical practice guidelines and who were treated with POMCIDEX. The period of retrospective data collection will be from 01/01/2015 to 01/01/2017.

The period of data collection for the study includes a maximum period of three months to allow each centre to collect the necessary clinical and demographic data for each patient in order to fulfill the different study objectives. Patient data will be anonymized and recorded in the electronic Case Report Form (eCRF) using the RedCap platform. Afterward, data cleansing and verification will be carried out on all data recorded by the study investigators. This procedure will be carried out in the six months after database lock.

Once the process of recording and verification of patient data is complete, extraction and statistical analysis of the data will be carried out.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Viability Study of the PETHEMA-POMCIDEX Clinical Practice Guidelines for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma (RRMM)
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : March 13, 2019
Estimated Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
Refractory Multiple Myeloma
Patients with relapsed and refractory multiple myeloma who have received treatment with pomalidomide, cyclophosphamide, and dexamethasone following the GEM-PETHEMA clinical practice guidelines between 01/01/2015 to 01/04/2018



Primary Outcome Measures :
  1. Level of compliance at PETHEMA centres in Spain with the clinical practice guidelines proposed by the Spanish Myeloma Group for the treatment of relapsed and refractory MM with POMCIDEX. [ Time Frame: 3 months ]
    To evaluate the viability of the therapeutic guidelines, measured in terms of compliance and the effectiveness of the treatment planned.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with POMCIDEX during the period 01/01/2015 and 01/04/2018 in accordance with the PETHEMA clinical practice guidelines. The inclusion criteria in the guidelines are those specified in the clinical practice guidelines
Criteria

Inclusion Criteria:

  • Patients treated with POMCIDEX during the period 01/01/2015 and 01/04/2018 in accordance with the PETHEMA clinical practice guidelines. The inclusion criteria in the guidelines are those specified in the clinical practice guidelines

Exclusion Criteria:

  • Patients who have not been treated according to the clinical practice guidelines during the specified period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477643


Locations
Spain
Hospital de Sant Joan de Déu Not yet recruiting
Barcelona, Spain
Contact: Cristina Motllo, Dr    + 34 932 53 21 00    cristinamotllo@gmail.com   
Hospital Donostia-Donostia Ospitalea Not yet recruiting
Donostia, Spain
Contact: Mailen Sirvent, Dr    + 34 943 00 70 00    MAIALEN.SIRVENTAUZMENDI@osakidetza.eus   
Hospital Universitario Virgen de Las Nieves Not yet recruiting
Granada, Spain
Contact: Rafael Rios, Dr    + 34 958 02 00 00    rriost33@gmail.com   
Hospital General San Jorge - Huesca Not yet recruiting
Huesca, Spain
Contact: Ilda Maria Murillo, Dr    + 34 974 24 70 00    immurillof@gmail.com   
Hospital de Jaén Not yet recruiting
Jaén, Spain
Contact: Soledad Duran, Dr    + 34 902 50 50 61    soledadduran@hotmail.com   
Hospital Lucus Augusti Not yet recruiting
Lugo, Spain
Contact: Esperanza la Villa, Dr    + 34 982 29 60 00    esperanza.lavilla.rubira@sergas.es   
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain
Contact: Belen Iñigo, Dr    + 34 913 30 30 01    belen.inigo@gmail.com   
Hospital Del Tajo Not yet recruiting
Madrid, Spain
Contact: Ana Lafuente, Dr    + 34 918 01 41 00    apaz.lafuenteguijosa@salud.madrid.org   
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain
Contact: Cristina Encinas, Dr    + 34 915 86 80 00    crisenro@hotmail.com   
Hospital Ramón Y Cajal Not yet recruiting
Madrid, Spain
Contact: Mª Jesus Blanchard, Dr    + 34 913 36 80 00    mjesusblanchard@yahoo.es   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan José Lahuerta, Dr    + 34 913 90 80 00    jjlahuerta@telefonica.net   
Hospital Universitario de La Princesa Not yet recruiting
Madrid, Spain
Contact: Adrián Alegre, Dr    + 34 915202200    adrian.alegre@telefonica.net   
Hospital Universitario Virgen de La Arrixaca Not yet recruiting
Murcia, Spain
Contact: Valentin Cabañas, Dr    + 34 968 36 95 00    valentin.cabanas@gmail.com   
Complejo Hospitalario de Especialidades Virgen de La Victoria Not yet recruiting
Málaga, Spain
Contact: Ricarda García, Dr    + 34 951 03 20 00    ricarda_g@yahoo.es   
Hospital Central de Asturias Not yet recruiting
Oviedo, Spain
Contact: Ana Pilar Gonzalez, Dr    + 34 985 10 80 00    anapilargonzalez@gmail.com   
Hospital Universitari Son Espases Not yet recruiting
Palma De Mallorca, Spain
Contact: Antonia Sampol, Dr    + 34 871 20 50 00    antonia.sampolm@ssib.es   
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Spain
Contact: Jose María Arguiñano Pérez, Dr    948 25 54 00    jm.arguinano.perez@cfnavarra.es   
Hospital El Bierzo Not yet recruiting
Ponferrada, Spain
Contact: Erik de Cabo, Dr    + 34 987 45 52 00    erikbierzo@hotmail.com   
Hospital Universitario de Salamanca Not yet recruiting
Salamanca, Spain
Contact: María Victoria Mateos, Dr    + 34 983 42 00 00    mvmateos@usal.es   
Hospital Mutua Terrassa Recruiting
Terrassa, Spain
Contact: Josep Mª Tutusaus, Dr    + 34 93 736 50 50    jmarti@mutuaterrassa.es   
Complejo Hospitalario de Toledo Not yet recruiting
Toledo, Spain
Contact: Luis Casado Montero, Dr    + 34 925 26 92 00    lfcasadom@telefonica.net   
Hospital Universitario Dr. Peset Aleixandre Not yet recruiting
Valence, Spain
Contact: Paz Ribas    + 34 961622300    ribas_paz@gva.es   
Hospital Arnau de Vilanova Not yet recruiting
Valencia, Spain
Contact: Aurelio Lopez, dr    + 34 973 705 246 ...    aureliolopmar@hotmail.com   
Hospital Universitario La Fe Not yet recruiting
Valencia, Spain
Contact: Mario Arnao, Dr    +34 961 244 350    arnao_mar@gva.es   
HOSPITAL CLíNICO UNIVERSITARIO DE VALLADOLID Recruiting
Valladolid, Spain
Contact: Alfonso García de Coca, Dr    +34 983 42 00 00    agarciadecoca@gmail.com   
Hospital Txagorritxu Not yet recruiting
Vitoria, Spain
Contact: Ernesto Pérez, Dr    + 34 945007000    ernesto.perezpersona@osakidetza.net   
Sponsors and Collaborators
PETHEMA Foundation

Additional Information:
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT03477643     History of Changes
Other Study ID Numbers: GEM-POMCIDEX
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases