Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03601624
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Martha Alvarado Ibarra, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Multiple Myeloma Progression Refractory Multiple Myeloma Drug: Pomalidomide Phase 2

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.


Layout table for study information
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)
Primary Purpose: Treatment
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


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:
  • Cyclophosphamide
  • Dexamethasone




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03601624


Contacts
Layout table for location contacts
Contact: MARTHA A ALVARADO, MD 0445525600960 normoblasto@gmail.com
Contact: JOSE LUIS ALVAREZ, MD 55525532257383 draselo@hotmail.com

Locations
Layout table for location information
Mexico
ISSSTE Recruiting
Ciudad de Mexico, Mexico, 03229
Contact: MARTHA A ALVARADO, MD    15525600960    normoblasto@gmail.com   
Sponsors and Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Investigators
Layout table for investigator information
Principal Investigator: MARTHA ALVARADO, MD Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Publications:
Martha Alvarado Ibarra, Manuel López Hernández, José LuisAlvarez Vera, Maricela Ortiz Zepeda, Verónica Mena Zepeda and Eugenia Espitia Ríos. Outcomes and Evolution In The Tratment Of Multiple Myeloma In The Last 20 Years Experience Of A Mexican Institution. International Journal of Information Research and Review 3(9):2811-2817, 2016

Layout table for additonal information
Responsible Party: Martha Alvarado Ibarra, Chief of Hematology Area, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
ClinicalTrials.gov Identifier: NCT03601624     History of Changes
Other Study ID Numbers: ISSSTE-POM-CY-MM-2018
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martha Alvarado Ibarra, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado:
Multiple Myeloma
Relapse
Progression
Pomalidomide

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Thalidomide
Neoplasms, Plasma Cell
Disease Progression
Recurrence
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
Disease Attributes
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents