Clinical trial · Interventional
Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
Multicenter Study of Pomalidomide, Cyclophosphamide, and Dexamethasone in Relapsed Refractory Myeloma: Safety Profile in Mexican Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Multiple Myeloma Progression | — | UNRESOLVED | — |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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 )
- interventionNames
- Drug: Pomalidomide
Primary outcomes (1)
- measure
- Safety: Incidence of Treatment - Emergent Adverse Events
- timeFrame
- 2 years
- description
- 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 outcomes (1)
- measure
- Efficacy as secondary endpoints: progression free survival, overall survival and overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDRichardson 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
- BACKGROUNDMiguel 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
- BACKGROUNDDimopoulos 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
- BACKGROUNDBaz 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
- BACKGROUNDMartha 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