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

• Status: Unknown status
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Treatments: BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone acetate; Pomalidomide; Thalidomide

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.