Overview

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

Status:
Terminated
Trial end date:
2019-05-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Treatments:
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone acetate
Lenalidomide
Pomalidomide
Thalidomide
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