Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans (MM-POM-2018)
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|ClinicalTrials.gov Identifier: NCT03601624|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : November 14, 2018
Despite available therapies, MM uniformly fatal and participants who have received prior lenalidomide (Len) and bortezomib have a median overall survival (OS) of 9 months.
Pomalidomide (Pom) plus low-dose dexamethasone (Dex) significantly improved efficacy parameters in terms of progression free survival (PFS), OS, and overall response (ORR) compared with high-dose Dex in participants with refractory or relapsed, and refractory MM, including participants with disease refractory to both bortezomib and lenalidomide.
Alkylating agents also represent standard therapies for participants with MM. There are some reports demonstrating combination of Len and continuous cyclophosphamide (Cy) achieve an ORR of 50% in Len refractory participants, suggesting Cy may be able to overcome resistance to Len.
The investigators aimed to assess the safety in Mexican MM participants in relapse/refractory stage of the triple combination: IV Cy in combination with Pom plus Dex until disease progression. A multicenter study is proposed.
Primary endpoint: Safety. Efficacy as secondary endpoint: PF, OS and ORR.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma in Relapse Multiple Myeloma Progression Refractory Multiple Myeloma||Drug: Pomalidomide||Phase 2|
Multiple myeloma is a plasma cell malignancy with accounts for about 1% of all cancers. Despite available therapies, the disease remains uniformly fatal and participants who have received prior lenalidomide and bortezomib have a median overall survival of 9 months.
Combination therapy is often used in clinical practice. In an attempt to overcome drug/clone resistance, other report with pomalidomide, dexamethasone and cyclophosphamide (PomCyDex) show efficacy and safety information, regimen for refractory myeloma patients with higher overall response rate than pomalidomide and dexamethasone.
In this case a phase II trial scheme is proposed: 1. Pomalidomide at 4 mg orally on days 1-21 of a 28 day cycle, 2. Cyclophosphamide 300 mg IV on days 1 and 15 of a 28 day cycle; and 3. Dexamethasone 40 mg PO weekly. Participants who were >75 years of age or those who were known to be intolerant to 40 mg weekly dexamethasone are going to receive 20 mg dexamethasone on the same schedule.
Pomalidomide is a drug wide studied in American and European population, but not in México. Even it has been approved by local Regulatory authority, there is not any trial supporting data about safety and efficacy in Mexican population. Alkylating agents are very active in MM, and in combination with novel therapies, such as immunomodulatory drugs, has shown to enhance efficacy in relapsed/refractory setting.
It is proposed phase 2 study to assess safety and efficacy of treatment with Pomalidomide in combination with Cyclophosphamide and dexamethasone in a sample of Mexican RRMM participants from ISSSTE.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Interventional phase 2, multicentric, open label|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||July 30, 2020|
- Safety: Incidence of Treatment - Emergent Adverse Events [ Time Frame: 2 years ]Adverse events leading to death or to discontinuation from treatment, events classified grade 3 or higher, study drug-related events, and serious adverse events are going to be listed separately.
- Efficacy as secondary endpoints: progression free survival, overall survival and overall response rate [ Time Frame: 2 years ]For the secondary end point, ORR and its 95% confidence interval are going to be calculated for the study groups using the exact binomial method
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): NCT03601624
|Contact: MARTHA A ALVARADO, MDfirstname.lastname@example.org|
|Contact: JOSE LUIS ALVAREZ, MDemail@example.com|
|Ciudad de Mexico, Mexico, 03229|
|Contact: MARTHA A ALVARADO, MD 15525600960 firstname.lastname@example.org|
|Principal Investigator:||MARTHA ALVARADO, MD||Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado|