Ankara University | Ibni-Sina Hospital - Rheumatology Department
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About
This trial will try to establish the feasibility and efficacy of the combination of DaraVCD in Multiple Myeloma (MM) patients presenting with extramedullary disease (EMD). The study will be conducted as a Phase II trial.
Forty patients will be included in the study cohort. All patients will be followed closely for toxicities and response assessment. After completion of treatment, patients will be followed every 6 months for survival until 5 years after enrolment
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
Newly diagnosed or relapsed (patients should have received a maximum of one line of prior therapy) patients presenting with extramedullary disease (EMD) of the skin, liver, lungs, central nervous system, lymph nodes or other tissues, but not solely paraskeletal plasmacytoma (expanding soft tissue masses)* detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy**. Documentation of plasma cell infiltration is highly recommended unless it requires invasive surgical intervention such as intracerebral infiltration of plasmacytomas.
*Note: patients with only paraosseous extension of MM forming soft tissue plasmacytomas are not eligible
**Note: An additional radiologic assessment at screening is not required to confirm EMD. Documentation in terms of physician's/pathologist's report and/or radiologic assessments performed within 42 days of C1D1 will suffice for the purposes of eligibility. All patients however will undergo a baseline radiologic assessment at C1D1 for response purposes.
Patients with one prior line of therapy must have:
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Note: for patients with central nervous system (CNS) involvement, an ECOG performance status >2 is also acceptable
Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
Patient must have measurable disease of MM as defined by the below criteria:
Reproductive Status
Exclusion criteria
Solitary plasmacytoma
Paraosseous extension of MM forming soft tissue plasmacytomas only (without EMD).
Previous therapy with any anti-CD38 or anti-CS1 monoclonal antibody
Patients refractory to bortezomib based regimens (PD on or within 60 days of completion of bortezomib OR failure to achieve at least a minimal response [MR]) as the prior line of therapy
Patients who have Bortezomib or Daratumumab hypersensitivity
Patients who have active or chronic infections
Patients who have received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 (C1D1). The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment before C1D1.
Previous autologous stem cell transplant (ASCT) within 12 weeks before C1D1.
Previous allogenic stem cell transplant (alloSCT) regardless of timing.
Patient has received radiotherapy within 14 days from C1D1. NOTE: Urgent localized radiotherapy for Spinal Cord Compression or Central Nervous System Involvement is allowed.
Patient has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and patients must be excluded if FEV1 <50% of predicted normal
Patient has known moderate or severe persistent asthma within the past 2 years (see) or currently has uncontrolled asthma of any classification. Note: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
Severe cardiovascular disease (arrhythmias [CTCAE Grade 3 or higher] requiring chronic treatment, congestive heart failure [New York Heart Association (NYHA) Class III - IV] or symptomatic ischemic heart disease);
Severe pulmonary dysfunction (CTCAE grade 3-4, see appendix D);
Severe neurological or psychiatric disease;
Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times the upper limit of normal (ULN)) unless related to hepatic involvement with MM.
Note: Patients with Gilbert Syndrome are not excluded provided that direct bilirubin is ≤2 x ULN.
Significant renal dysfunction (creatinine clearance <30 ml/min after rehydration) Note: refer to Appendix F for creatinine clearance calculation;
Significant bone marrow suppression as evidenced by any of the below laboratory tests during screening:
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, active systemic infection, uncontrolled hypertension, cancer, etc.) that is likely to interfere with the study procedures/results or which, in the opinion of the investigator, would constitute a hazard for participating in this study.
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
Any of the following:
EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (antiHBs 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.
o Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy).
Patient known to be HIV-positive;
Current participation in another clinical trial
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Primary purpose
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41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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