Study of Pomalidomide, Oral Dexamethasone and Very Low-dose Cyclophosphamide in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib

NCT04243109 | Terminated Phase 2

• 1 other identifier: FCO-PDC-2015-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial with a pharmaceutical specialty in a new combination. Pomalidomide in combination with dexamethasone is indicated in the treatment of adult patients with multiple treatment-resistant or relapsing myeloma who have received at least two previous treatments, including lenalidomide and bortezomib, and who have experienced a disease progression in the last treatment. The combination of Pomalidomide with Cyclophosphamide at metronomic doses (Very low doses) and Dexamethasone is tested in this clinical situation.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Pomalidomide; Cyclophosphamide; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Best response

  Evaluate the best response rate based on the criteria of the International Myeloma Working Group of the following responses at the end of each cycle or during the maintenance period.

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

Secondary Outcomes (9)

• Time to Response

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

• Duration of Response

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

• Time to Progression

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

• Global Survival

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

• Progression Free Survival

  Every 28 days (each cycle is 28 days) from randomization until progression or withdrawal of the subject, whichever came first, assessed up to 60 months.

Study Arms (1)

Pomalidomide + Cyclophosphamide + Dexamethasone

EXPERIMENTAL

Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles: * Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. * Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles. * Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained.

Drug: Pomalidomide + Cyclophosphamide + Dexamethasone

Interventions

Pomalidomide + Cyclophosphamide + Dexamethasone DRUG

Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles: * Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. Dose reductions will be made based on the evaluation of hematological and non-hematological toxicity. * Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles. * Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. In patients older than 75 years the dose will be reduced to 20 mg / day in the same previous schedule. Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained.

Pomalidomide + Cyclophosphamide + Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Patient over 18 years of age and who meets criteria 2 and / or 3.
• Patient diagnosed with symptomatic Multiple Myeloma according to standard criteria.
• Patients with symptomatic multiple myeloma in relapse / refractory after having received treatment with at least two cycles that include Bortezomib and with at least two cycles that include Lenalidomide, whether combined in the same therapeutic scheme or as part of different chemotherapy schemes.
• Patients with MM with measurable disease, defined as the presence of monoclonal component of at least 0.5 g / dL in serum or at least 0.2 g / d in urine, or in those without measurable disease the presence of altered light chain radius at the time of entry into the study.
• Patients with good general condition defined as ECOG ≤ 2.
• The patient must understand the written informed consent and sign it of his own accord.
• The patient must be able to meet all scheduled visits and other requirements.
• Laboratory Criteria: Patients must present the following counts:Absolute neutrophils: ≥1000 / μL, Platelet Count: ≥50,000 / μL, Hemoglobin:\> 8 gr / dL, Total bilirubin: \<2 x upper limit of normal, AST and ALT: \<3 x Upper limit of normal, Serum potassium: within the limits of normality.
• Women of childbearing age should have a negative pregnancy test.
• The male patient included in the trial must commit to always use a latex condom during any sexual contact with women of childbearing age, even if they have undergone a successful vasectomy.

You may not qualify if:

• Any concomitant disease, laboratory alteration or psychiatric disorder that may presuppose the subject's inability to sign the IC.
• PS\> 3 according to the ECOG scale.
• Previous history of non-hematologic malignancies, unless the patient has been free of the disease for ≥ 5 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast.
• Patients who are unable or unwilling to undergo antithrombotic therapy.
• Known positive serology for human immunodeficiency virus HIV or active infectious hepatitis, type B, or C.
• Depressed heart function, or clinically significant heart disease
• Severe hypercalcemia
• Any serious medical condition, including laboratory alterations that cause the patient to take an unacceptable risk if participating in this study or that may interfere with the interpretation of the study data.
• Patients treated with any investigational drug in the previous 28 days.
• Any severe medical condition, abnormality in laboratory tests or any psychiatric illness that prevents the signing of written consent.
• Pregnant or breastfeeding women.
• Known hypersensitivity to drugs or compounds of biological or chemical composition similar to those of the study.
• Plasma Cell Leukemia

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Cyclophosphamide; 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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Miguel Ángel Álvarez Rivas, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: January 28, 2020
• Study Start: February 23, 2017
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Open, under previous request.
• Access Criteria: To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (1)