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New treatment option for Multiple Myeloma
Official title Personalized Autologous Transplant for Multiple Myeloma
ClinicalTrials.gov ID: NCT04483206
What this study is testing
What is Melphalan?
Melphalan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as Alkeran.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the best dose and side effects of mephalan in treating patients with multiple myeloma who are undergoing stem cell transplant. Chemotherapy drugs, such as mephalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must have the clinical diagnosis of a plasma cell neoplasm requiring treatment per the treating physician using the International Myeloma...
- If enrolling in phase A of this protocol, the patient
- must have received 2+ lines of therapy as defined by the IMWG; and
- Must have estimated glomerular filtration rate (eGFR) by Cockcroft-Gault \> 40 mL/min; and
- Be eligible and appropriate per the treating physician to receive 200 mg/m\^2
You likely can't join if
- Patients known to meet criteria for progressive disease or clinical relapse between screening and planned melphalan infusion day -3
- Subject has any of the following cardiac abnormalities
- History of clinically significant cardiovascular disease with New York Heart Association class III or IV congestive heart failure or
- Severe non-ischemic cardiomyopathy or
- Myocardial infarction within the previous 6 months prior to starting study treatment
- Unstable or poorly controlled angina
See the full eligibility criteria
- Patient must have the clinical diagnosis of a plasma cell neoplasm requiring treatment per the treating physician using the International Myeloma Working Group (IMWG) and World Health Organization (WHO) criteria as...
- If enrolling in phase A of this protocol, the patient
- must have received 2+ lines of therapy as defined by the IMWG; and
- Must have estimated glomerular filtration rate (eGFR) by Cockcroft-Gault \> 40 mL/min; and
- Be eligible and appropriate per the treating physician to receive 200 mg/m\^2
- If enrolling in phase B of the protocol, the transplant must be part of first line therapy to provide some level of homogeneity for toxicity assessment and preliminary how well it works
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelet count \>= 100,000
- Total bilirubin \< 1.5 x institutional upper limit of normal (unless the patient has an established diagnosis of Gilbert's in which case total bilirubin \< 3 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x the institutional upper limit of normal
- Left ventricular ejection fraction \>= 45%
- Diffusion capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC) \> 50% of predicted value (corrected for hemoglobin)
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%) is required for eligibility. Those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. The effects of protocol therapy on the developing human fetus are unknown. For this reason, FCBP and...
- The patient must be willing to comply with fertility requirements
- Ability to understand and the willingness to sign a written informed consent document
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients known to meet criteria for progressive disease or clinical relapse between screening and planned melphalan infusion day -3
- Subject has any of the following cardiac abnormalities
- History of clinically significant cardiovascular disease with New York Heart Association class III or IV congestive heart failure or
- Severe non-ischemic cardiomyopathy or
- Myocardial infarction within the previous 6 months prior to starting study treatment
- Unstable or poorly controlled angina
- Uncontrolled severe hypertension
- Clinically/hemodynamically significant arrythmias
- Severe uncontrolled cardiac arrhythmias (grade 3 or higher) or
- Clinically significant electrocardiogram (ECG) abnormalities includingcorrected QT interval (QTc) \> 480 msec
- Human immunodeficiency virus (HIV) positive EXCEPT if the patient meets all the following: CD4 \> 350 cells/mm\^3, undetectable viral load, maintained on modern therapeutic regimen utilizing non CYP interacting agents...
- Seropositive for hepatitis B surface antigen [HBsAg]) EXCEPT people with resolved infection (ie, people who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface...
- Seropositive for hepatitis C except in the setting of a sustained virologic response [SVR], defined as without viremia for at least 12 weeks after completion of antiviral therapy
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin change (POEMS) syndrome, amyloid light-chain (AL) amyloidosis, and Waldenstrom macroglobulinemia
- Concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for...
- Known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder) or the subject has any condition for which, in the opinion of the...
- Pregnant women are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.