Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
NCT ID: NCT03336073
Last Updated: 2022-09-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
199 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-12-18
Study Completion Date
2024-12-31
Brief Summary
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This is a multicenter, open label, phase II randomized controlled study that will evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in R/R MM patients.
For this purpose, R/R MM patients that have received 1-3 prior lines of therapy, and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive:
* Experimental arm: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles; or
* Control arm: the same treatment but without cyclophosphamide.
Once the first 12 cycles are administered, treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms.
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2. If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.
Treatment will be continued until progression, unacceptable toxicity or investigator or patient decision.
For this purpose, R/R MM patients that have received 1-3 prior lines of therapy, and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive:
* Experimental arm: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles; or
* Control arm: the same treatment but without cyclophosphamide.
Once the first 12 cycles are administered, treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms.
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2. If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.
Treatment will be continued until progression, unacceptable toxicity or investigator or patient decision.
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Detailed Description
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Treatment will consist of 28-days cycles with:
* Arm 1 (experimental arm):
* Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8 and 15.
* Dexamethasone at a dose of 20 mg po (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16.
* Cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
* Arm 2 (control arm):
* Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8, and 15.
* Dexamethasone at a dose of 20 mg po (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16.
Once the first 12 cycles are administered, treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms.
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2. If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.
Treatments will be administered until progressive disease (PD) or unacceptable toxicity. Carfilzomib and cyclophosphamide will be provided by the sponsor. Dexamethasone may be utilized per a site's standard practice and will not be provided by the sponsor.
* Arm 1 (experimental arm):
* Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8 and 15.
* Dexamethasone at a dose of 20 mg po (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16.
* Cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
* Arm 2 (control arm):
* Carfilzomib administered iv at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) iv on days 1, 8, and 15.
* Dexamethasone at a dose of 20 mg po (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16.
Once the first 12 cycles are administered, treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms.
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2. If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3.
Treatments will be administered until progressive disease (PD) or unacceptable toxicity. Carfilzomib and cyclophosphamide will be provided by the sponsor. Dexamethasone may be utilized per a site's standard practice and will not be provided by the sponsor.
Conditions
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Multiple Myeloma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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carfilzomib, dexamethasone and cyclophosphamide
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles
Group Type
EXPERIMENTAL
Carfilzomib
Intervention Type
DRUG
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15
Dexamethasone
Intervention Type
DRUG
dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16
cyclophosphamide
Intervention Type
DRUG
cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
carfilzomib and dexamethasone
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16 , in 28 days cycles
Group Type
ACTIVE_COMPARATOR
Carfilzomib
Intervention Type
DRUG
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15
Dexamethasone
Intervention Type
DRUG
dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16
Interventions
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Carfilzomib
carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15
Intervention Type
DRUG
Dexamethasone
dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16
Intervention Type
DRUG
cyclophosphamide
cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
Intervention Type
DRUG
Eligibility Criteria
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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 (Lancet Oncology 2014) that after previous treatment with 1-3 regimens require therapy due to a relapse/progression of the disease.
6. Patients must have measurable disease, defined as follows:
* Serum monoclonal protein ≥ 0.5 g/L, or
* Urine light-chain excretion of ≥ 0.2g /24 hours, or
* Abnormal ratio of serum free light chains (FLCs) plus involved FLC level ≥100 mg/L.
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 (Lancet Oncology 2014) that after previous treatment with 1-3 regimens require therapy due to a relapse/progression of the disease.
6. Patients must have measurable disease, defined as follows:
* Serum monoclonal protein ≥ 0.5 g/L, or
* Urine light-chain excretion of ≥ 0.2g /24 hours, or
* Abnormal ratio of serum free light chains (FLCs) plus involved FLC level ≥100 mg/L.
Exclusion Criteria
1. Primary refractory patients defined as not having achieved at least a PR with a prior therapy.
2. Refractoriness to prior proteasome inhibitor therapies, defined as not having achieved at least MR or having progressed under treatment or in the first 60 days after the last dose of the proteasome inhibitor.
3. Biochemical and haematological abnormalities as specified below:
* Hemoglobin \< 8.0 g/dL.
* Platelet count \<75x109/L without previous platelet transfusions in the last 7 days. If bone marrow infiltration is greater than 50%, a platelet count of ≥50x109/L is required.
* Absolute neutrophil count (ANC) \< 0.75 x109/L without G-CSF support in the last 7 days.
* Aspartate transaminase (AST): \> 2.5 times the upper limit of normal.
* Alanine transaminase (ALT): \> 2.5 times the upper limit of normal.
* Calculated or measured creatinine clearance: \<30 mL/min (calculated from the Cockcroft and Gault formula, specified in Appendix C).
4. Left ventricle ejection fraction \< 50%.
5. Absence of recovery from any significant non-haematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade \< 2 symptomatic peripheral neuropathy is allowed.
6. Pregnant or breastfeeding women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, and oral contraception).
7. 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).
8. Other relevant diseases or adverse clinical conditions:
* Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
* 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).
* History of significant neurological or psychiatric disorders.
* Active infection
* Significant non-neoplastic liver disease (e.g. cirrhosis, active chronic hepatitis).
9. Patient is known to be human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or to suffer active hepatitis C infection
10. The patient has received concomitant anti-myeloma therapy within 14 days prior to Day 1 of Cycle 1.
11. Limit to the patient's ability to comply with the treatment or follow-up protocol.
12. 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).
2. Refractoriness to prior proteasome inhibitor therapies, defined as not having achieved at least MR or having progressed under treatment or in the first 60 days after the last dose of the proteasome inhibitor.
3. Biochemical and haematological abnormalities as specified below:
* Hemoglobin \< 8.0 g/dL.
* Platelet count \<75x109/L without previous platelet transfusions in the last 7 days. If bone marrow infiltration is greater than 50%, a platelet count of ≥50x109/L is required.
* Absolute neutrophil count (ANC) \< 0.75 x109/L without G-CSF support in the last 7 days.
* Aspartate transaminase (AST): \> 2.5 times the upper limit of normal.
* Alanine transaminase (ALT): \> 2.5 times the upper limit of normal.
* Calculated or measured creatinine clearance: \<30 mL/min (calculated from the Cockcroft and Gault formula, specified in Appendix C).
4. Left ventricle ejection fraction \< 50%.
5. Absence of recovery from any significant non-haematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade \< 2 symptomatic peripheral neuropathy is allowed.
6. Pregnant or breastfeeding women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, and oral contraception).
7. 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).
8. Other relevant diseases or adverse clinical conditions:
* Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
* 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).
* History of significant neurological or psychiatric disorders.
* Active infection
* Significant non-neoplastic liver disease (e.g. cirrhosis, active chronic hepatitis).
9. Patient is known to be human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or to suffer active hepatitis C infection
10. The patient has received concomitant anti-myeloma therapy within 14 days prior to Day 1 of Cycle 1.
11. Limit to the patient's ability to comply with the treatment or follow-up protocol.
12. 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Site Status
H.Universitari Germans Trias I Pujol de Badalona
Barcelona, , Spain
Site Status
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Site Status
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
Ico L'Hospitalet
Barcelona, , Spain
Site Status
Complejo Hospitalario de Cáceres
Cáceres, , Spain
Site Status
Hospital de Cabueñes
Gijón, , Spain
Site Status
Centro Hospitalario Universitario de Granada
Granada, , Spain
Site Status
Hospital de León
León, , Spain
Site Status
H. 12 de Octubre
Madrid, , Spain
Site Status
H. Ramón y Cajal
Madrid, , Spain
Site Status
Hospital Sanchinarro
Madrid, , Spain
Site Status
Hospital Costa del Sol
Málaga, , Spain
Site Status
Hospital Universitario Morales Meseguer
Murcia, , Spain
Site Status
Hospital Virgn de la Arrixaca
Murcia, , Spain
Site Status
Hospital Central de Asturias
Oviedo, , Spain
Site Status
Hospital de Son Llàtzer
Palma de Mallorca, , Spain
Site Status
Clinica Universitaria de Navarra
Pamplona, , Spain
Site Status
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital Universitario de Santiago
Santiago de Compostela, , Spain
Site Status
Hospital de Segovia
Segovia, , Spain
Site Status
Complejo Hospitalario Regional Virgen Del Rocío
Seville, , Spain
Site Status
Hospital de Toledo
Toledo, , Spain
Site Status
Hospital Lozano Blesa
Zaragoza, , Spain
Site Status
Countries
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Spain
References
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BACKGROUND
Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006 Jul 1;24(19):3187-205. doi: 10.1200/JCO.2006.06.4451. Epub 2006 May 8.
Reference Type
BACKGROUND
Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.
Reference Type
BACKGROUND
Suzuki E, Demo S, Deu E, Keats J, Arastu-Kapur S, Bergsagel PL, Bennett MK, Kirk CJ. Molecular mechanisms of bortezomib resistant adenocarcinoma cells. PLoS One. 2011;6(12):e27996. doi: 10.1371/journal.pone.0027996. Epub 2011 Dec 22.
Reference Type
BACKGROUND
Vij R, Wang M, Kaufman JL, Lonial S, Jakubowiak AJ, Stewart AK, Kukreti V, Jagannath S, McDonagh KT, Alsina M, Bahlis NJ, Reu FJ, Gabrail NY, Belch A, Matous JV, Lee P, Rosen P, Sebag M, Vesole DH, Kunkel LA, Wear SM, Wong AF, Orlowski RZ, Siegel DS. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma. Blood. 2012 Jun 14;119(24):5661-70. doi: 10.1182/blood-2012-03-414359. Epub 2012 May 3.
Reference Type
BACKGROUND
Puertas B, Gonzalez-Calle V, Sureda A, Moreno MJ, Oriol A, Gonzalez E, Rosinol L, Lopez J, Escalante F, Martinez-Lopez J, Carrillo E, Clavero E, Rios-Tamayo R, Rey-Bua B, Gonzalez-Rodriguez AP, Dourdil V, De Arriba F, Gonzalez S, Perez-de-Oteyza J, Hernandez MT, Garcia-Mateo A, Bargay J, Blade J, Lahuerta JJ, San Miguel JF, Ocio EM, Mateos MV. Randomized phase II study of weekly carfilzomib 70 mg/m2 and dexamethasone with or without cyclophosphamide in relapsed and/or refractory multiple myeloma patients. Haematologica. 2023 Oct 1;108(10):2753-2763. doi: 10.3324/haematol.2022.282490.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GEM-KyCyDex
Identifier Type: -
Identifier Source: org_study_id
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