Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans (MM-POM-2018)

November 13, 2018 updated by: Martha Alvarado Ibarra, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de Mexico, Mexico, 03229
        • Recruiting
        • ISSSTE
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years old
  2. Relapsed and refractory multiple myeloma patients that had received ≥2 prior lines of therapies including a proteasome inhibitor and Lenalidomide; if cyclophosphamide was included in a previous line, complete scheme has to be finished at least 6 months previously to initiate in this IIT.
  3. Measurable disease as defined by the presence of 1 of the following: serum monoclonal protein ≥0.5 g/dL; urine monoclonal protein >200 mg/24 h; or serum involved free light chain ≥10 mg/dL and abnormal serum free light chain ratio.
  4. ECOG 0 to 2
  5. Serum creatinine level <3mg/dL.
  6. Absolute neutrophil count ≥1000/mm3, and a platelet count ≥30 000/mm3.
  7. Females of childbearing potential has to have a negative serum or urine pregnancy test within 10 to 14 days prior to, and within 24 hours of, starting pomalidomide.
  8. A washout period of 2 weeks prior to cycle 1 day 1 from prior therapies are required.

Exclusion Criteria:

  1. Patients with known hypersensitivity to thalidomide or lenalidomide
  2. Patients who had HIV or active hepatitis B or C;
  3. Patients with grade 3 or more neuropathy
  4. Patients with active malignancy requiring therapy within the next year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
  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 )
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 )
Other Names:
  • Dexamethasone
  • Cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Investigators

  • Principal Investigator: MARTHA ALVARADO, MD, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSSTE-POM-CY-MM-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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