Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

NCT03336073 | Unknown Phase 2

• 1 other identifier: GEM-KyCyDex
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS is defined as the number of months from randomization to the disease progression or death due to any cause, whichever occurs first. The disease outcome determined will be the primary data source for the final PFS analysis.

  36 months

Secondary Outcomes (5)

• Safety of carfilzomib, dexamethasone and cyclophosphamide in number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2 years

• Efficacy of carfilzomib, dexamethasone and cyclophosphamide in number and rate of responses obtained

  2 years

• Time-to progression (TTP)

  36 months

• Overall Survival (OS)

  36 months

• Efficacy of carfilzomib, dexamethasone and cyclophosphamide in rate of achievement of immunophenotypic CR

  2 years

Study Arms (2)

carfilzomib, dexamethasone and cyclophosphamide

EXPERIMENTAL

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

Drug: Carfilzomib; Drug: Dexamethasone; Drug: cyclophosphamide

carfilzomib and dexamethasone

ACTIVE COMPARATOR

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

Drug: Carfilzomib; Drug: Dexamethasone

Interventions

Carfilzomib 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

carfilzomib and dexamethasone; carfilzomib, dexamethasone and cyclophosphamide

Dexamethasone DRUG

dexamethasone oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16

carfilzomib and dexamethasone; carfilzomib, dexamethasone and cyclophosphamide

cyclophosphamide DRUG

cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15

carfilzomib, dexamethasone and cyclophosphamide

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 (Lancet Oncology 2014) that after previous treatment with 1-3 regimens require therapy due to a relapse/progression of the disease.
• 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.

You may not qualify if:

• Primary refractory patients defined as not having achieved at least a PR with a prior therapy.
• 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.
• 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).
• Left ventricle ejection fraction \< 50%.
• 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.
• 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).
• 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).
• Other relevant diseases or adverse clinical conditions:
• 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).

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (24)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Location

H.Universitari Germans Trias I Pujol de Badalona

Barcelona, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Ico L'Hospitalet

Barcelona, Spain

Location

Complejo Hospitalario de Cáceres

Cáceres, Spain

Location

Hospital de Cabueñes

Gijón, Spain

Location

Centro Hospitalario Universitario de Granada

Granada, Spain

Location

Hospital de León

León, Spain

Location

H. 12 de Octubre

Madrid, Spain

Location

H. Ramón y Cajal

Madrid, Spain

Location

Hospital Sanchinarro

Madrid, Spain

Location

Hospital Costa del Sol

Málaga, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, Spain

Location

Hospital Virgn de la Arrixaca

Murcia, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Hospital de Son Llàtzer

Palma de Mallorca, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital de Segovia

Segovia, Spain

Location

Complejo Hospitalario Regional Virgen Del Rocío

Seville, Spain

Location

Hospital de Toledo

Toledo, Spain

Location

Hospital Lozano Blesa

Zaragoza, Spain

Location

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Dexamethasone; Cyclophosphamide

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 8, 2017
• Study Start: December 18, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

ES (24)