Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients

NCT02384083 | Completed Phase 1 DMC

• 1 other identifier: POMDEFIL
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

Brief Summary

Phase I/II, Multicenter, Open Label, Clinical Trial to evaluate safety and efficacy and determine the Maximum Tolerated Dose (MTD) of Filanesib in combination with pomalidomide and dexamethasone in relapsed/refractory (R/R) Multiple Myeloma (MM) patients

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Pethema; Filanesib; Pomalidomide

Outcome Measures

Primary Outcomes (1)

• Maxim Tolerability Dose measured by common toxicity criteria v4.0

  6 months

Secondary Outcomes (1)

• Eficcacy measured by the rate of responses

  6 months

Study Arms (1)

Filanesib, pomalidomide and dexamethasone

EXPERIMENTAL

28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 \& 16, + pomalidomide administered p.o. at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 \& 22

Drug: Filanesib, pomalidomide and dexamethasone

Interventions

Filanesib, pomalidomide and dexamethasone DRUG

Patients will be treated with 28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 \& 16, + pomalidomide administered p.o. at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 \& 22. G-CSF prophylaxis is mandatory in all patients after Filanesib, starting from Day 3 and Day 17 (for a total of 7 days each). Treatment will be continued until progression or unacceptable toxicity.

Filanesib, pomalidomide and dexamethasone

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Performance status (ECOG) ≤ 2.
• Patient is, in the Investigator's opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written Informed Consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Patients previously diagnosed with MM according to the IMWG Criteria (Blood 2011) that after previous treatment with at least 2 regimens require therapy due to a relapse/progression of the disease.
• Regarding the disease history, patient must:
• Have received 2 prior lines of therapy including bortezomib and lenalidomide.
• Be refractory or intolerant to lenalidomide.
• Be refractory to the last line of therapy.
• Refractoriness to any therapy is defined as either failure to achieve minimal response with it, or development of progressive disease (PD) while on therapy or within 60 days after finishing it.
• At least two cycles of treatment must have been received, unless PD is documented earlier.
• Only for the Phase II, patients must have measurable disease, defined as any of the following:
• Serum monoclonal protein value ≥ 500 mg/dl.
• Urine light chain excretion ≥ 200 mg/24 hours.
• Abnormal serum free light chains (FLCs) ratio plus involved FLC level ≥ 10 mg/dl.

You may not qualify if:

• Prior therapy with Filanesib or pomalidomide.
• Non-adequate hematological or biochemical parameters as specified below:
• Hemoglobin \< 8.0 g/dl.
• Platelets count \< 75 x109/L without previous platelet transfusions in the last 7 days. If high bone marrow infiltration (\>50%) is present, ≥ 50 x109/L platelet count is required.
• Neutrophils (ANC) \<1.5 × 109/L without growth factor support (defined as no growth factor administration for at least 14 days prior to observation). If the bone marrow contains ≥ 50% plasma cells, a neutrophil count ≥1.0 × 109/L is allowed.
• Aspartate transaminase (AST): \> 2.5 x the upper limit range.
• Alanine transaminase (ALT): \> 2.5 x the upper limit range.
• Total bilirubin: \> 2 x the upper limit range.
• Creatinine clearance: \< 45 mL/min (measured or calculated with the Cockcroft and Gault formula).
• Absence of recovery from any significant non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade \< 2 symptomatic peripheral neuropathy is allowed.
• Concomitant anti-myeloma therapy, including corticosteroids at a dose greater than 10 mg/d prednisone or equivalent, within 14 days prior to Day 1 of Cycle 1.
• Pregnant or lactating women; men and women of reproductive potential who are not using highly effective contraceptive methods.
• Previous history of any other malignancy in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).
• Prior allogeneic bone marrow transplantation in the six prior months or active GVHD in the past month prior to cycle 1, day 1.
• Other relevant diseases or adverse clinical conditions:

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Array BioPharma: collaborator
• Celgene Corporation: collaborator

Study Sites (10)

Instoitut Català d'Oncologia

Badalona, 08916, Spain

Location

Hospital Clinico Universitario

Barcelona, 08036, Spain

Location

Hospital Doce de Octubre

Madrid, 28041, Spain

Location

Hospital Morales Messeguer

Murcia, 30008, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario Salamanca

Salamanca, 37007, Spain

Location

Hospital General de Segovia

Segovia, 40002, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Dr Peset

Valencia, 46017, Spain

Location

Hospital Lozano Blesa

Zaragoza, 50009, Spain

Location

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Related Links

• Pethema Foundation

MeSH Terms

Conditions

Multiple Myeloma

Interventions

filanesib; pomalidomide; 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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ocio Enrique, DR

  PETHEMA Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 10, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: March 23, 2020
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

ES (10)