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New drug cocktail may boost stem cell transplant success in blood cancer
NCT ID NCT01453101
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drug bortezomib to the standard chemotherapy before a donor stem cell transplant could help people with multiple myeloma live longer without their cancer getting worse. Fifty-four adults received the new drug combo. The main goal was to see if this approach improved the time until the cancer progressed or the patient died, compared to past results with the standard two-drug regimen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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54 people
The number who actually took part.
- Started
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Jun 2010
- Finished
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Jun 2020
- 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 69 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: * Diagnosis of multiple myeloma * Have a suitable related or unrelated donor * Age ≥18 but \<70 yrs * KPS of ≥70% * Recovery from complications of previous therapies Exclusion Criteria: * Diagnosis other than multiple myeloma * Chemotherapy or radiotherapy within 21 days of initiating treatment in this study * Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study * Uncontrolled bacterial, viral, fungal or parasitic infections * Uncontrolled CNS metastases * Known amyloid deposition in heart * Organ dysfunction * LVEF \<40% or cardiac failure not responsive to therapy * FVC, FEV1, or DLCO \<50% of predicted and/or receiving supplementary continuous oxygen * Evidence of hepatic synthetic dysfunction, or total bilirubin \>2x or AST \>3x ULN * Measured creatinine clearance \<20 ml/min * Sensory peripheral neuropathy grade 4 within 14 days of enrollment * Karnofsky score \<70% unless a result of bone disease directly caused by myeloma * Life expectancy limited by another co-morbid illness * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy * Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Documented hypersensitivity to fludarabine or melphalan or to bortezomib, boron or mannitol or any components of the formulation * Patients unable or unwilling to provide consent * Patient has a sustained platelet count of \<30 x 10 9/L within 14 days before enrollment * Patient has a sustained absolute neutrophil count of \<1.0 x10 9/L within 14 days before enrollment * 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. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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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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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?