Clinical trial to evaluate a new combination of drugs (Filanesib + pomalidomide + dexamethasone) for the treatment of relapsed or refractory (drug-resistant) multiple myeloma.

Phase 1

• Conditions: Patients with Multiple Myeloma in relapsed or refractory; MedDRA version: 17.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002740-41-ES
• Lead Sponsor: Fundación Pethema

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Age ?18 years.
2.Performance status (ECOG) ? 2.
3.Patient is, in the Investigator's opinion, willing and able to comply
with the protocol requirements.
4.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care, with the understanding that consent may be withdrawn by the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.
5.Patients previously diagnosed with MM according to the IMWG Criteria
(Blood 2011) that after previous treatment with one or more regimens
require therapy due to a relapse/progression of the disease.
6.Regarding the disease history, patient must:
a.Have received 2 prior lines of therapy including bortezomib and
lenalidomide.
b.Be refractory or intolerant to lenalidomide.
c.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.)
7.Only for the Phase II, patients must have measurable disease, defined
as any of the following:
a.Serum monoclonal protein value ? 500 mg/dl.
b.Urine light chain excretion ? 200 mg/24 hours.
c.Abnormal serum free light chains (FLCs) plus involved FLC level
? 10 mg/dl.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1.Prior therapy with Filanesib or pomalidomide.
2.Non-adequate hematological or biochemical parameters as specified
below:
a.Hemoglobin < 8.0 g/dl.
b.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.
c.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.
d.Aspartate transaminase (AST): > 2.5 x the upper limit range.
e.Alanine transaminase (ALT): > 2.5 x the upper limit range.
f.Total bilirubin: > 2 x the upper limit range.
g.Creatinine clearance: < 45 mL/min (measured or calculated
with the Cockcroft and Gault formula).
3.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.
4.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.
5.Pregnant or lactating women; men and women of reproductive
potential who are not using effective contraceptive methods (double
barrier method, intrauterine device, oral contraception).
6.Previous history of any other neoplastic disease in the last five years
(except basal cell carcinoma, skin epithelioma or carcinoma in situ of
any site).
7.Other relevant diseases or adverse clinical conditions:
a.Congestive heart failure or angina pectoris, myocardial
infarction within 12 months before inclusion in the study.
b.Uncontrolled arterial hypertension or cardiac arrhythmias (i.e.
requiring a change in medication within the last 3 months or a hospital
admission within the past 6 months).
c.History of significant neurological or psychiatric disorders.
d.Active infection.
e.Significant non-neoplastic liver disease (e.g., cirrhosis, active
chronic hepatitis).
f.Uncontrolled endocrine diseases (e.g. diabetes mellitus,
hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in
medication within the last month, or hospital admission within the last 3
months).
8.Patient is known to be human immunodeficiency virus (HIV) positive,
Hepatitis B surface antigen-positive or active hepatitis C infection.
9.Limitation of the patient's ability to comply with the treatment or
follow-up protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?To evaluate safety and determine the MTD of Filanesib in combination<br>with pomalidomide and dexamethasone in R/R Multiple Myeloma (MM)<br>patients.;Secondary Objective: N/A;Primary end point(s): ?The grade and frequency of clinical and laboratory toxicities (AE/SAEs),<br>DLTs, and treatment discontinuations after Filanesib in combination with<br>pomalidomide + dexamethasone<br>?MTD of the combination of Filanesib + pomalidomide + dexamethasone;Timepoint(s) of evaluation of this end point: ?During the treatment<br>?During the treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A