New chemo formula aims to boost transplant success in blood cancers
NCT ID NCT02909036
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new, more stable version of the chemotherapy drug melphalan in people with multiple myeloma or AL amyloidosis who are getting a stem cell transplant. The goal is to find the best dose that reaches a target level in the body, while possibly causing fewer side effects like electrolyte problems or organ damage. About 46 adults aged 18 to 75 with responsive disease are participating.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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46 people
The number who actually took part.
- Started
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Sep 2016
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 and ≤ 75 * Patients must have either: * Symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease): Patients who are receiving high-dose melphalan and AHCT as part of their initial therapy require at least a partial response (PR) as defined by the International Myeloma Working Group uniform response criteria for MM. Patients who are receiving high-dose melphalan and AHCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease. There is no limit on the number of prior regimens received by the patient. OR * Light chain (AL) amyloidosis who may be newly diagnosed or previously treated * Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma or AL amyloidosis. Standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines * Patients must have at least 3 x 10\^6 CD34+ cells/kg frozen. * Adequate organ function is required, defined as follows: * Serum bilirubin ≤ 2.0 mg/dl * AST, ALT and alkaline phosphatase \< 3 times the upper limit of laboratory normal * Creatinine clearance ≥ 40 ml/min (24 hour urine collection) * LVEF ≥ 45% by MUGA or rest ECHO * Diffusing capacity ≥ 45% (adjusted for hemoglobin) predicted by pulmonary function testing * Performance status (ECOG) ≤ 2 * A willingness to avoid pregnancy or fathering children in male and female subjects respectively * A woman of childbearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) at screening and must be willing to avoid pregnancy during the study treatment period and for a specified duration (1 year post HCT) after the end of treatment. * Women of childbearing potential who have a negative serum pregnancy test at screening must practice a highly effective method of birth control (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed. * Men who are enrolled must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed Exclusion Criteria: * Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker * Light chain (AL) amyloidosis patients with Mayo Cardiac Stage IIIB (defined as NT-proBNP\>8500 ng/L and Cardiac troponin (cTnT) \>0.035 μg/L) * Pregnant or lactating females * Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas * Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim * Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial * Any known allergy or allergic reactions to Captisol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas