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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03477643
Other study ID # GEM-POMCIDEX
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 27, 2018
Est. completion date July 14, 2020

Study information

Verified date February 2021
Source PETHEMA Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 01/04/2018. 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 14, 2020
Est. primary completion date July 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital de Sant Joan de Déu Barcelona
Spain Hospital Donostia-Donostia Ospitalea Donostia
Spain Hospital Universitario Virgen de Las Nieves Granada
Spain Hospital General San Jorge - Huesca Huesca
Spain Hospital de Jaén Jaén
Spain Hospital Lucus Augusti Lugo
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Del Tajo Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Ramón Y Cajal Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Complejo Hospitalario de Especialidades Virgen de La Victoria Málaga
Spain Hospital Universitario Virgen de La Arrixaca Murcia
Spain Hospital Central de Asturias Oviedo
Spain Hospital Universitari Son Espases Palma De Mallorca
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital El Bierzo Ponferrada
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Mutua Terrassa Terrassa
Spain Complejo Hospitalario de Toledo Toledo
Spain Hospital Universitario Dr. Peset Aleixandre Valence
Spain Hospital Arnau de Vilanova Valencia
Spain Hospital Universitario La Fe Valencia
Spain HOSPITAL CLíNICO UNIVERSITARIO DE VALLADOLID Valladolid
Spain Hospital Txagorritxu Vitoria

Sponsors (1)

Lead Sponsor Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. To evaluate the viability of the therapeutic guidelines, measured in terms of compliance and the effectiveness of the treatment planned. 3 months
See also
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Completed NCT03029234 - Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma Phase 3
Recruiting NCT05530421 - Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma Phase 2
Not yet recruiting NCT03559764 - Study of BCMA CAR-T in Multiple Myeloma Early Phase 1
Completed NCT02144038 - Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma Phase 1
Terminated NCT00664378 - Efficacy Study of CYT997 in Multiple Myeloma Phase 2
Terminated NCT03710915 - A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma Phase 1
Terminated NCT02223598 - A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies Phase 1
Recruiting NCT03661554 - BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma Early Phase 1

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