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Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans

NCT03601624 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Myeloma in Relapse
  • Multiple Myeloma Progression
  • Refractory Multiple Myeloma

Interventions

DRUG

Pomalidomide

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. 3. Dexamethasone 40 mg PO weekly.(Or 20 mg if patients are older than 75 years )

Sponsors & Collaborators

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

    lead OTHER_GOV

Principal Investigators

  • MARTHA ALVARADO, MD · Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2018-12-31
Completion
2020-07-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601624 on ClinicalTrials.gov