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

NCT ID: NCT04243109

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2019-05-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pomalidomide + Cyclophosphamide + Dexamethasone

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.

Group Type: EXPERIMENTAL

Pomalidomide + Cyclophosphamide + Dexamethasone

Intervention Type: 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.

Interventions

Pomalidomide + Cyclophosphamide + Dexamethasone

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Major surgical interventions within 15 days prior to inclusion or not having recovered from their side effects.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Ángel Álvarez Rivas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario Reina Sofía

Córdoba, , Spain

Countries

Spain

Other Identifiers

FCO-PDC-2015-01

Identifier Type: -

Identifier Source: org_study_id