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

NCT03601624 | Unknown Phase 2

• 1 other identifier: ISSSTE-POM-CY-MM-2018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma Progression; Refractory Multiple Myeloma

Keywords

Multiple Myeloma; Relapse; Progression; Pomalidomide

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of Treatment - Emergent Adverse Events

  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 Outcomes (1)

• Efficacy as secondary endpoints: progression free survival, overall survival and overall response rate

  2 years

Study Arms (1)

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

Interventions

Pomalidomide DRUG

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 )

Also known as: Cyclophosphamide, Dexamethasone

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• 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.
• 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.
• ECOG 0 to 2
• Serum creatinine level \<3mg/dL.
• Absolute neutrophil count ≥1000/mm3, and a platelet count ≥30 000/mm3.
• 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.
• A washout period of 2 weeks prior to cycle 1 day 1 from prior therapies are required.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

ISSSTE

Mexico City, 03229, Mexico

RECRUITING

Related Publications (5)

• Richardson PG, Mark TM, Lacy MQ. Pomalidomide: new immunomodulatory agent with potent antiproliferative effects. Crit Rev Oncol Hematol. 2013 Oct;88 Suppl 1:S36-44. doi: 10.1016/j.critrevonc.2013.02.001. Epub 2013 Jun 17.

  PMID: 23786844 BACKGROUND

• Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.

  PMID: 24007748 BACKGROUND

• Dimopoulos MA, Leleu X, Palumbo A, Moreau P, Delforge M, Cavo M, Ludwig H, Morgan GJ, Davies FE, Sonneveld P, Schey SA, Zweegman S, Hansson M, Weisel K, Mateos MV, Facon T, Miguel JF. Expert panel consensus statement on the optimal use of pomalidomide in relapsed and refractory multiple myeloma. Leukemia. 2014 Aug;28(8):1573-85. doi: 10.1038/leu.2014.60. Epub 2014 Feb 5.

  PMID: 24496300 BACKGROUND

• Baz RC, Martin TG 3rd, Lin HY, Zhao X, Shain KH, Cho HJ, Wolf JL, Mahindra A, Chari A, Sullivan DM, Nardelli LA, Lau K, Alsina M, Jagannath S. Randomized multicenter phase 2 study of pomalidomide, cyclophosphamide, and dexamethasone in relapsed refractory myeloma. Blood. 2016 May 26;127(21):2561-8. doi: 10.1182/blood-2015-11-682518. Epub 2016 Mar 1.

  PMID: 26932802 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Disease Progression

Interventions

pomalidomide; Cyclophosphamide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• MARTHA ALVARADO, MD

  Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARTHA A ALVARADO, MD

CONTACT

0445525600960; normoblasto@gmail.com

JOSE LUIS ALVAREZ, MD

CONTACT

55525532257383; draselo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Hematology Area

Model Details: Interventional phase 2, multicentric, open label

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: July 30, 2020
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

ME (1)