Daratumumab Carfilzomib Pomalidomide Dexamethasone In MM

  • STATUS
    Recruiting
  • End date
    May 5, 2025
  • participants needed
    43
  • sponsor
    Andrew Yee, MD
Updated on 5 November 2021
platelet count
filgrastim
granulocyte colony stimulating factor
dexamethasone
lenalidomide
colony stimulating factor
carfilzomib
refractory multiple myeloma

Summary

This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma.

This research study involves two study drugs and two standard of care drugs.

  • The names of the study drugs involved in this study are:
  • Carfilzomib
  • Daratumumab
  • The names of the standard of care drugs involved in this study are:
  • Dexamethasone
  • Pomalidomide

Description

This phase II, multicenter, open-label study is studying daratumumab in combination with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma who have received at least one prior therapy and who have had previous treatment with both lenalidomide and a proteasome inhibitor.

  • The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves two study drugs and two standard of care drugs.
  • The names of the study drugs involved in this study are:
  • Carfilzomib
  • Daratumumab
  • The names of the standard of care drugs involved in this study are:
  • Dexamethasone
  • Pomalidomide
  • A total of 43 participants will be enrolled to this trial
  • The U.S. Food and Drug Administration (FDA) has not approved Daratumumab, and Carfilzomib for use in treatment of Multiple Myeloma.

Details
Condition Recurrent Disease, Relapse, multiple myeloma (mm), Lymphoproliferative Disorder, Multiple Myeloma in Relapse, relapsed disease, Lymphoproliferative disorders, Refractory Multiple Myeloma, Multiple Myeloma
Treatment Pomalidomide, Dexamethasone, Daratumumab, Carfilzomib
Clinical Study IdentifierNCT04176718
SponsorAndrew Yee, MD
Last Modified on5 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women 18 and 80 years old
Diagnosis of multiple myeloma
Serum monoclonal protein 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
mg of monoclonal protein in the urine on 24 hour electrophoresis
Serum free light chain 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
Previously treated relapsed and refractory multiple myeloma
Patients must have received at least one prior line of therapy
Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
Disease progression on or within 60 days of completion of last therapy
ANC 1000/L
G-CSF is not permitted within 14 days of screening
Patients with ANC <1000/L can be considered for screening on a case by case basis with additional monitoring, after discussion with and approval from the PI
Platelet count 50,000/L. Platelet transfusion is not permitted within 7 days of screening
Hemoglobin 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria
Calculated creatinine clearance of 30 mL/min by Cockcroft-Gault equation
Patient has adequate hepatic function, as evidenced by each of the following
Serum bilirubin values < 2 mg/dL; and
Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 2.5 the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin)
Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent
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
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken)

Exclusion Criteria

Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study registration or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received dexamethasone within 2 weeks prior to study registration
Participants who are receiving any other investigational agents
Last line of therapy with the combination of carfilzomib, pomalidomide, and dexamethasone. Note, prior treatment with daratumumab or other anti-CD38 therapy is permitted. Prior treatment with carfilzomib or pomalidomide is permitted (as different lines of treatment but not in the same combination)
Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose 10 mg/day prednisone equivalent) is permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc
Pregnancy or lactation or planned lactation (breastfeeding)
Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for 3 years. Patients who are free of disease < 3 years may enroll after discussion with and approval of the PI. Exceptions include the following (i.e. the following are eligible to participate)
Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Ductal carcinoma in situ of the breast
Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance
Patients with plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial
Seropositive for HIV infection
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]; see exception below). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. Exception: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Peripheral neuropathy grade 2 despite supportive therapy
Hypersensitivity to daratumumab, thalidomide, lenalidomide, pomalidomide, carfilzomib, or dexamethasone (such as Stevens-Johnson syndrome). Rash to immunomodulatory drug that can be medically managed is allowable
Allogeneic stem cell transplant <12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least four weeks prior to initiation of study treatment and who are currently dependent on such treatment. Patients may also not have active graft v. host disease (GVHD)
Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association [NYHA] Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months
Known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <60% of predicted normal), known moderate or severe persistent asthma within 2 years prior to study registration (intermittent asthma is allowed). Patient with known or suspected COPD or asthma must have an FEV1 test within 28 days prior to study registration
Major surgery within 2 weeks prior to C1D1
Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
Toxicity from previous anticancer therapy must resolve to baseline levels or to grade 1, except for alopecia and peripheral neuropathy
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