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NCT03417284CompletedPhase 1/2

Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation

Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 1 May 2025

Brief summary (registry, in English)

This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
62 (actual)
First submitted
24 Jan 2018
Start date
9 Oct 2019
Primary completion date
18 Jul 2024
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT03417284

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 62
  • From 9 Oct 2019 to the primary completion date, 18 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
  • Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patients participating in an investigational new drug protocol within 14 days before enrollment.
  • Prior hematopoietic cell transplantation allogeneic or autologous (A prior autologous HCT will be allowed as long as it was part of tandem transplantation).
  • Prior organ transplant requiring immunosuppressive therapy

Other illness

  • Patients seropositive for the human immunodeficiency virus (HIV).

Other

  • Female patients who are pregnant (positive beta-human chorionic gonadotropin \[b-HCG\]) or breast feeding.

Who the study is looking for

  • Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR
  • Patients with non-secretory multiple myeloma (absence of a monoclonal protein \[M protein\] in serum as measured by electrophoresis \[serum protein electrophoresis (SPEP)\] and immunofixation (serum immunofixation electrophoresis \[SIFE\]) and the absence of Bence Jones protein in the urine \[urine protein electrophoresis (UPEP)\] defined by use of conventional electrophoresis and immunofixation \[urine immunofixation electrophoresis (UIFE) techniques\]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan.
  • Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
  • Karnofsky performance score 70% or higher.
  • Left ventricular ejection fraction at rest \> 40% within 3 months of registration.
  • Bilirubin \< 2 x the upper limit of normal (except patients with Gilbert syndrome in whom bilirubin level of \> 2 x upper normal limit will be allowed)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x the upper limit of normal.
  • Creatinine clearance of \>= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation.
  • Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) \> 50% of predicted value (corrected for hemoglobin) within 3 months of registration.
  • All female and male subjects of reproductive potential must consent to the use of effective contraceptive methods as advised by the study doctor during treatment.
  • Signed informed consent form.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.