Ixazomib + Pomalidomide + Dexamethasone In MM

  • STATUS
    Recruiting
  • End date
    Mar 20, 2022
  • participants needed
    61
  • sponsor
    Paul G. Richardson, MD
Updated on 25 February 2021
platelet count
measurable disease
dexamethasone
neutrophil count
imid
proteasome inhibitor
refractory multiple myeloma
ixazomib
pomalidomide
pomalyst
immunomodulatory imide drug

Summary

This is a Phase I/II study using the combination of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed and or refractory multiple myeloma (RRMM) patients.

Description

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.

The FDA has approved both pomalidomide and ixazomib individually for the treatment of multiple myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.

  • Ixazomib targets a part of cells called proteasomes. It works by slowing down or blocking proteasomes from doing their job of digesting proteins. In myeloma cells, there is a greater need for proteasomes to digest proteins; the buildup of excess proteins causes cell death.
  • Pomalidomide has also been shown to cause tumor cell deaths. Dexamethasone can stop white blood cells from traveling to areas myeloma cells are causing damage. When combined with myeloma drugs, it sometimes makes those drugs work better.

In this research study, the investigators are:

  • Testing the safety of ixazomib when given with pomalidomide and dexamethasone
  • Pomalidomide and ixazomib are given individually for the treatment of multiple myeloma. Dexamethasone is also given for multiple myeloma
  • Ixazomib when combined with pomalidomide and dexamethasone may help control the disease
  • Ixazomib is FDA approved to treat multiple myeloma
  • The investigators are looking for the highest dose of ixazomib that can be given safely in combination with pomalidomide and dexamethasone

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Multiple Myeloma in Relapse, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Pomalidomide, Dexamethasone, Ixazomib
Clinical Study IdentifierNCT04094961
SponsorPaul G. Richardson, MD
Last Modified on25 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with relapsed and relapsed refractory myeloma may be eligible for this trial of they meet all the following entry criteria
Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment
Patient has given voluntary written informed consent before performance of any study-related procedures 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
Patient had received at least two previous therapies OR received 1 prior line of therapy if previously treated with an IMiD plus a proteasome inhibitor and has demonstrated disease progression on or within 60 days of completion of the last therapy
Patient has measurable disease defined as at least one of the following according to Standard Diagnostic Criteria (Rajkumar 2014)
Serum IgG, IgA, or IgM M-protein 0.5 g/dL, or
Serum IgD M-protein 0.05 g/dL, or
Urine M protein 200 mg/24 hours or
Serum free light chain (FLC) assay: Involved FLC assay 10 mg/dL (100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
Screening Laboratory evaluations within the following parameters
Absolute neutrophil count (ANC) 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used more recently than 14 days prior to initiation of therapy)
Platelet count 75,000 cells/dL (75 x 109/L) (without transfusions required during the 14 days prior to initiation of therapy)
Hemoglobin 8.0 g/dl (RBC transfusions are permitted)
Total Bilirubin 1.5 X upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
AST (SGOT) and ALT (SGPT) 3.0 x ULN
Calculated creatinine clearance 45 mL/min
ECOG performance status 2 (Karnofsky 60%, see Appendix A)
All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Prior exposure to ixazomib OR is refractory to pomalidomide
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib,whether treated with the agent or not, are also excluded
Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
Known GI disease or is in need of, or has had a previous GI procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide including difficulty swallowing
Known central nervous system involvement
Systemic treatment, within 14 days before the first dose of treatment, with strong CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin, fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine)
Any medical or psychiatric illness/social situation that in the Investigator's opinion, would impose excessive risk to the patient, would adversely affect his/her participating in this study or would limit compliance with study requirements
Any active, or uncontrolled cardiovascular conditions, including but not limited to uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction within the past 6 months
The following therapies within the stated time frames prior to initiation of therapy
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 21 days (42 days for nitrosoureas)
The use of live vaccines within 30 days
ImiDs or proteasome inhibitors within 14 days
Other investigational therapies and/or monoclonal antibodies within 4 weeks
Prior peripheral stem cell transplant within 12 weeks
Prior allogeneic stem cell transplantation with active graft-versus-host-disease
Currently active graft versus host disease of any stage or grade after allogeneic stem cell transplantation
Prior major surgical procedure or radiation therapy within 14 days of initiation of therapy
Those who require a limited course of radiation for management of bone pain more than 14 days out from initiation of therapy are not excluded
If the involved field is small, 7 days will be considered a sufficient interval between radiotherapy and administration of the ixazomib
Daily requirement for corticosteroids (equivalent to > 10 mg/day prednisone, though >10mg/day is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy. Inhalation corticosteroids are exempt from this criterion
\-- Lower amounts of corticosteroids that are not part of a daily requirement
within 14 days prior to initiating therapy
Concurrent symptomatic amyloidosis or plasma cell leukemia
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
\-- Those who are on prophylactic antibiotics only, or on antibiotics and have
confirmation of resolution of active infection are eligible
Known seropositive for active viral infection with human immunodeficiency virus (HIV) hepatitis B (HBV) or hepatitis C viral (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Participants who are receiving any other investigational agents for any indication
History of erythema multiforme or severe hypersensitivity to prior IMiD's or those who have a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Inability to tolerate thromboprophylaxis
Failure to have fully recovered ( Grade 1 according to CTCAE v 5) from the reversible effects of prior chemotherapy
Peripheral neuropathy must have resolved to Grade 1 toxicity or peripheral neuropathy grade 2 with no pain to be eligible
Alopecia of any grade is eligible
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