Multiple MyelomaPhase 1/2NCT02384083
Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients
A Phase 1/2 study testing Filanesib, pomalidomide and dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 10 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Filanesib, pomalidomide and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 10 sitesSpain
- Study dates
- Sep 2015to 23 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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:
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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:
- Congestive heart failure or unstable angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- Uncontrolled arterial hypertension or unstable cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
- History of significant neurological or psychiatric disorders.
- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
- 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).
- Patient is known to be human immunodeficiency virus (HIV) positive, Hepatitis B surface antigen-positive or active hepatitis C infection.
- Limitation of the patient's ability to comply with the treatment or follow-up protocol.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Instoitut Català d'Oncologia
Badalona, 08916
Hospital Clinico Universitario
Barcelona, 08036
Hospital Doce de Octubre
Madrid, 28041
Hospital Morales Messeguer
Murcia, 30008
Clínica Universitaria de Navarra
Pamplona, 31008
Hospital Clinico Universitario Salamanca
Salamanca, 37007
Hospital General de Segovia
Segovia, 40002
Hospital Virgen del Rocío
Seville, 41013
Hospital Universitario Dr Peset
Valencia, 46017
Hospital Lozano Blesa
Zaragoza, 50009
About this study
Official title: Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients
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
Read the detailed description
National, multicenter, open label single-arm, non-comparative study, that will evaluate the MTD and the efficacy of the Kinesin Spindle Protein (KSP) inhibitor Filanesib (ARRY-520) in combination with pomalidomide + dexamethasone in relapsed or refractory MM patients.
For this purpose, relapsed or refractory MM patients after at least two prior lines of therapy including bortezomib and lenalidomide, who are refractory or intolerant to lenalidomide and refractory to the last line of therapy 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 po 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.
Initially, a Phase I will be conducted using a modified 3+3 dose-escalating algorithm. The first three patients will be enrolled in the first dose level (see Figure 1 for dose escalation levels). If no DLT occurs among them, the next cohort of three patients will continue at the next higher dose level. If a DLT occurs among the first three evaluable patients during the first cycle, three more patients will be enrolled at the same dose level.
If no more than one DLT is observed among the six evaluable patients in this expanded dose group during cycle 1, enrollment will continue at the next higher dose level following the same scheme.
If more than one DLT occurs among the three or six evaluable patients included in the 1st cohort, an alternative dose escalation will be started, with a reduction of the dose of pomalidomide (see Figure 1). Patients will be then treated following again the same 3+3 algorithm. If more than one DLT out of three or six patients occur at the first dose level of the alternative escalation, the study will be stopped.
MTD will be considered as the dose level in which ≤1 DLT are observed among 6 evaluable patients, therefore, at least six patients must be treated at a given dose before this dose is considered the MTD.
Once the MTD is determined in Phase I, additional patients will be treated at this dose in the Phase II portion of the trial in order to define the activity and further define the toxicity of the combination at the MTD.
Patient participation in the study will comprise several periods:
The pre-treatment period includes the screening visit. After providing the written Informed Consent form to participate in the study, patients will be evaluated for eligibility during a screening period of up to 21 days (Days -21 to -1).
During the treatment period, all patients will receive Filanesib in combination with pomalidomide and dexamethasone in 28-days-cycles until progression or unacceptable toxicity.
Patients receiving the combination will be evaluated for efficacy and toxicity after the completion of each cycle.
No intra-patient escalation will be performed, that is, patients included at a given dose level during the Phase I will remain at this dose level during all treatment unless a dose reduction is required for toxicity.
All patients that discontinue treatment for any other cause different to disease progression will be evaluated in the follow-up period every two months for 1 additional year, for disease status, survival and safety (including second primary malignancies). All patients that have progressed at the end of treatment will be followed for survival and safety only (including second primary malignancy), being phone contact acceptable.
Patients will be considered to be on-study from the signature of the Informed Consent to the end of the follow-up period. Patients will be considered to be on-treatment for the duration of their treatment and in the first 30 days following treatment discontinuation. Treatment discontinuation is defined as the day of the last study drug dose administration.
Patients will receive the study combination while it is considered to be in their best interest. Specifically, treatment will continue until one or more of the following events occur:
- Disease progression.
- Unacceptable toxicity.
- Patient refusal.
- Intercurrent serious illness.
- Protocol deviation with an effect on the risk/benefit ratio of the clinical trial.
- Treatment delay > 4 weeks (except in case of clear clinical benefit, with the sponsors' approval).
- Study closure.
- Conditions
- Multiple Myeloma
- Being tested
- Filanesib, pomalidomide and dexamethasone
- Keywords
- Multiple Myeloma, Pethema, Filanesib, Pomalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filanesib, pomalidomide and dexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Filanesib, pomalidomide and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxim Tolerability Dose measured by common toxicity criteria v4.0
Measured: 6 months
Secondary outcomes (1)
Eficcacy measured by the rate of responses
Efficacy of the Kinesin Spindle Protein (KSP) inhibitor Filanesib (ARRY-520) in combination with pomalidomide + dexamethasone in relapsed or refractory MM patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Array BioPharma, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Ocio Enrique, DR, Principal investigator, PETHEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384083
- Sponsor's protocol ID
- POMDEFIL
- Status last verified
- Jul 2022
- First submitted
- 1 Mar 2015
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004 Oct 28;351(18):1860-73. doi: 10.1056/NEJMra041875. No abstract available.
PubMed 15509819Kyle RA, Rajkumar SV. Multiple myeloma. Blood. 2008 Mar 15;111(6):2962-72. doi: 10.1182/blood-2007-10-078022.
PubMed 18332230Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, LeLeu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blade J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29.
PubMed 21799510Ocio EM, Richardson PG, Rajkumar SV, Palumbo A, Mateos MV, Orlowski R, Kumar S, Usmani S, Roodman D, Niesvizky R, Einsele H, Anderson KC, Dimopoulos MA, Avet-Loiseau H, Mellqvist UH, Turesson I, Merlini G, Schots R, McCarthy P, Bergsagel L, Chim CS, Lahuerta JJ, Shah J, Reiman A, Mikhael J, Zweegman S, Lonial S, Comenzo R, Chng WJ, Moreau P, Sonneveld P, Ludwig H, Durie BG, Miguel JF. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG). Leukemia. 2014 Mar;28(3):525-42. doi: 10.1038/leu.2013.350. Epub 2013 Nov 20.
PubMed 24253022Mateos MV, Ocio EM, San Miguel JF. Novel generation of agents with proven clinical activity in multiple myeloma. Semin Oncol. 2013 Oct;40(5):618-33. doi: 10.1053/j.seminoncol.2013.07.005.
PubMed 24135407Miguel 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.
PubMed 24007748Ocio EM, Mitsiades CS, Orlowski RZ, Anderson KC. Future agents and treatment directions in multiple myeloma. Expert Rev Hematol. 2014 Feb;7(1):127-41. doi: 10.1586/17474086.2014.858595. Epub 2013 Dec 18.
PubMed 24350987Blangy A, Lane HA, d'Herin P, Harper M, Kress M, Nigg EA. Phosphorylation by p34cdc2 regulates spindle association of human Eg5, a kinesin-related motor essential for bipolar spindle formation in vivo. Cell. 1995 Dec 29;83(7):1159-69. doi: 10.1016/0092-8674(95)90142-6.
PubMed 8548803Stern BM, Murray AW. Lack of tension at kinetochores activates the spindle checkpoint in budding yeast. Curr Biol. 2001 Sep 18;11(18):1462-7. doi: 10.1016/s0960-9822(01)00451-1.
PubMed 11566107Tunquist BJ, Woessner RD, Walker DH. Mcl-1 stability determines mitotic cell fate of human multiple myeloma tumor cells treated with the kinesin spindle protein inhibitor ARRY-520. Mol Cancer Ther. 2010 Jul;9(7):2046-56. doi: 10.1158/1535-7163.MCT-10-0033. Epub 2010 Jun 22.
PubMed 20571074Boiani M, Daniel C, Liu X, Hogarty MD, Marnett LJ. The stress protein BAG3 stabilizes Mcl-1 protein and promotes survival of cancer cells and resistance to antagonist ABT-737. J Biol Chem. 2013 Mar 8;288(10):6980-90. doi: 10.1074/jbc.M112.414177. Epub 2013 Jan 22.
PubMed 23341456Lonial S, Shah JJ, Zonder J, Bensinger WI, Cohen AD, Kaufman JL, et al. Prolonged Survival and Improved Response Rates With ARRY-520 In Relapsed/Refractory Multiple Myeloma (RRMM) Patients With Low α-1 Acid Glycoprotein (AAG) Levels: Results From a Phase 2 Study. Blood. 2013;122(21):285-
Shah JJ, Thomas S, Weber DM, Wang M, Orlowski R. Phase 1 Study Of The Novel Kinesin Spindle Protein Inhibitor Arry-520 + Carfilzomib(Car) In Patients With Relapsed And/Or Refractory Multiple Myeloma (RRMM). Haematologica. 2013;98(S1):Abstract-S579
Humphries MJ, Anderson D, Williams L, Rieger R, Tunquist B, Walker D. ARRY-520 Combined With Pomalidomide Displays Enhanced Anti-Tumor Activity In Preclinical Models Of Multiple Myeloma. Blood. 2013;122(21):3167
Petrelli NJ, Winer EP, Brahmer J, Dubey S, Smith S, Thomas C, Vahdat LT, Obel J, Vogelzang N, Markman M, Sweetenham JW, Pfister D, Kris MG, Schuchter LM, Sawaya R, Raghavan D, Ganz PA, Kramer B. Clinical Cancer Advances 2009: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology. J Clin Oncol. 2009 Dec 10;27(35):6052-69. doi: 10.1200/JCO.2009.26.6171. Epub 2009 Nov 9. No abstract available.
PubMed 19901123
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in Combination With Pomalidomide and Dexamethasone for Relapsed/Refractory (R/R) Multiple Myeloma (MM) Patients
- ClinicalTrials.gov ID
- NCT02384083
- Acronym / sponsor ID
- POMDEFIL
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Pethema, Filanesib, Pomalidomide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Collaborators
- Array BioPharma, Celgene Corporation
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
National, multicenter, open label single-arm, non-comparative study, that will evaluate the MTD and the efficacy of the Kinesin Spindle Protein (KSP) inhibitor Filanesib (ARRY-520) in combination with pomalidomide + dexamethasone in relapsed or refractory MM patients.
For this purpose, relapsed or refractory MM patients after at least two prior lines of therapy including bortezomib and lenalidomide, who are refractory or intolerant to lenalidomide and refractory to the last line of therapy 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 po 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.
Initially, a Phase I will be conducted using a modified 3+3 dose-escalating algorithm. The first three patients will be enrolled in the first dose level (see Figure 1 for dose escalation levels). If no DLT occurs among them, the next cohort of three patients will continue at the next higher dose level. If a DLT occurs among the first three evaluable patients during the first cycle, three more patients will be enrolled at the same dose level.
If no more than one DLT is observed among the six evaluable patients in this expanded dose group during cycle 1, enrollment will continue at the next higher dose level following the same scheme.
If more than one DLT occurs among the three or six evaluable patients included in the 1st cohort, an alternative dose escalation will be started, with a reduction of the dose of pomalidomide (see Figure 1). Patients will be then treated following again the same 3+3 algorithm. If more than one DLT out of three or six patients occur at the first dose level of the alternative escalation, the study will be stopped.
MTD will be considered as the dose level in which ≤1 DLT are observed among 6 evaluable patients, therefore, at least six patients must be treated at a given dose before this dose is considered the MTD.
Once the MTD is determined in Phase I, additional patients will be treated at this dose in the Phase II portion of the trial in order to define the activity and further define the toxicity of the combination at the MTD.
Patient participation in the study will comprise several periods:
The pre-treatment period includes the screening visit. After providing the written Informed Consent form to participate in the study, patients will be evaluated for eligibility during a screening period of up to 21 days (Days -21 to -1).
During the treatment period, all patients will receive Filanesib in combination with pomalidomide and dexamethasone in 28-days-cycles until progression or unacceptable toxicity.
Patients receiving the combination will be evaluated for efficacy and toxicity after the completion of each cycle.
No intra-patient escalation will be performed, that is, patients included at a given dose level during the Phase I will remain at this dose level during all treatment unless a dose reduction is required for toxicity.
All patients that discontinue treatment for any other cause different to disease progression will be evaluated in the follow-up period every two months for 1 additional year, for disease status, survival and safety (including second primary malignancies). All patients that have progressed at the end of treatment will be followed for survival and safety only (including second primary malignancy), being phone contact acceptable.
Patients will be considered to be on-study from the signature of the Informed Consent to the end of the follow-up period. Patients will be considered to be on-treatment for the duration of their treatment and in the first 30 days following treatment discontinuation. Treatment discontinuation is defined as the day of the last study drug dose administration.
Patients will receive the study combination while it is considered to be in their best interest. Specifically, treatment will continue until one or more of the following events occur:
- Disease progression.
- Unacceptable toxicity.
- Patient refusal.
- Intercurrent serious illness.
- Protocol deviation with an effect on the risk/benefit ratio of the clinical trial.
- Treatment delay > 4 weeks (except in case of clear clinical benefit, with the sponsors' approval).
- Study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filanesib, pomalidomide and dexamethasone | Experimental | Drug: Filanesib, pomalidomide and dexamethasone28-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filanesib, pomalidomide and dexamethasonePatients 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. | Drug | Filanesib, pomalidomide and dexamethasone |
Primary outcome
Maxim Tolerability Dose measured by common toxicity criteria v4.0
Time frame: 6 months
1 secondary outcome
Eficcacy measured by the rate of responses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 15509819Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004 Oct 28;351(18):1860-73. doi: 10.1056/NEJMra041875. No abstract available.
- Background: PubMed 18332230Kyle RA, Rajkumar SV. Multiple myeloma. Blood. 2008 Mar 15;111(6):2962-72. doi: 10.1182/blood-2007-10-078022.
- Background: PubMed 21799510Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, LeLeu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blade J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29.
- Background: PubMed 24253022Ocio EM, Richardson PG, Rajkumar SV, Palumbo A, Mateos MV, Orlowski R, Kumar S, Usmani S, Roodman D, Niesvizky R, Einsele H, Anderson KC, Dimopoulos MA, Avet-Loiseau H, Mellqvist UH, Turesson I, Merlini G, Schots R, McCarthy P, Bergsagel L, Chim CS, Lahuerta JJ, Shah J, Reiman A, Mikhael J, Zweegman S, Lonial S, Comenzo R, Chng WJ, Moreau P, Sonneveld P, Ludwig H, Durie BG, Miguel JF. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG). Leukemia. 2014 Mar;28(3):525-42. doi: 10.1038/leu.2013.350. Epub 2013 Nov 20.
- Background: PubMed 24135407Mateos MV, Ocio EM, San Miguel JF. Novel generation of agents with proven clinical activity in multiple myeloma. Semin Oncol. 2013 Oct;40(5):618-33. doi: 10.1053/j.seminoncol.2013.07.005.
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- Pethema FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ocio Enrique, DR principal investigator
PETHEMA Foundation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Filanesib, pomalidomide and dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxim Tolerability Dose measured by common toxicity criteria v4.0 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384083, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.