Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
NCT ID: NCT03417284
Last Updated: 2025-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
62 participants
INTERVENTIONAL
2019-10-09
2024-07-18
Brief Summary
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Detailed Description
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I. To determine the optimal dose and schedule of melphalan for injection (melphalan hydrochloride \[Evomela\]) prior to autologous hematopoietic stem cell transplantation (auto-HCT) for multiple myeloma (MM).
II. To collect the pharmacokinetic data and compare the exposure-response evaluations between the 2 infusion schedules.
SECONDARY OBJECTIVES:
I. To determine the incidence of treatment related mortality (TRM) at day 90 after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.
II. To determine the rate of minimal residual disease (MRD) negative complete response (CR) rate at day 90 after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.
III. To determine the progression-free survival (PFS) after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.
OUTLINE: This is a phase I, dose escalation study of melphalan hydrochloride followed by a phase II study.
PREPARATIVE REGIMEN: Participants are randomized to 1 of 2 groups.
GROUP 1: Participants receive melphalan hydrochloride intravenously (IV) over 30-60 minutes on day -2.
GROUP 2: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz subcutaneously (SC) once daily (QD) starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an absolute neutrophil count (ANC) of 0.5 x 10\^9/L.
After completion of study treatment, participants are followed up at 3 months, every 3 months for 1 year, and then annually for 1 year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (melphalan hydrochloride, HSCT, filgrastim)
PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 30-60 minutes on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation
Undergo HSCT
Filgrastim-sndz
Given SC
Melphalan Hydrochloride
Given IV
Group 2 (melphalan hydrochloride, HSCT, filgrastim)
PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.
TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.
POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L.
Autologous Hematopoietic Stem Cell Transplantation
Undergo HSCT
Filgrastim-sndz
Given SC
Melphalan Hydrochloride
Given IV
Interventions
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Autologous Hematopoietic Stem Cell Transplantation
Undergo HSCT
Filgrastim-sndz
Given SC
Melphalan Hydrochloride
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patients seropositive for the human immunodeficiency virus (HIV).
* 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.
* Female patients who are pregnant (positive beta-human chorionic gonadotropin \[b-HCG\]) or breast feeding.
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Qaiser Bashir
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-00906
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0399
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0399
Identifier Type: -
Identifier Source: org_study_id
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