New hope for myeloma patients with chromosome abnormalities?
NCT ID NCT00572169
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment plan for people newly diagnosed with multiple myeloma, a type of blood cancer. The plan combines several drugs, including bortezomib and melphalan, with stem cell transplants and long-term maintenance therapy. The goal is to see if this approach works better than previous treatments, especially for patients with certain chromosome changes. 177 adults are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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177 people
The number who actually took part.
- Start date
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Nov 2006
- Expected to finish
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Aug 2027
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 years and older
- 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: * Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy. * Protein criteria must be present (quantifiable serum M-component of IgG, IgA, IgD, or IgE; urinary kappa or lambda light chain; or serum free light chain (SFLC) levels in order to evaluate response. Non-secretory patients are eligible provided the patient has \> 20% plasmacytosis OR multiple (\>3) focal plasmacytomas or focal lesions on MRI OR diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors. * Patients must have received no more than one cycle or one month of prior chemotherapy for this disease. Patients may have received prior radiotherapy provided approval has been obtained by the Principal Investigator. * Patients must be \<75 years of age at the time of initial registration. * Ejection fraction by ECHO or MUGA ≥ 40% performed within 60 days prior to registration. * Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \> 50% of predicted, within 60 days of registration. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy. * Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. * All patients must be informed of the investigational nature of this study and must have signed an IRB-approved informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Platelet count \< 30 x 109/L, unless myeloma-related. * 5.1.2.2 Grade \> 2 peripheral neuropathy. * Hypersensitivity to bortezomib, boron, or mannitol. * Uncontrolled diabetes. * Recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. * Evidence of chronic obstructive or chronic restrictive pulmonary disease. * Patients must not have light chain deposition disease or creatinine \> 3 mg/dl * Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds five years. * Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. * Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
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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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University of Arkansas for Medical Sciences/Myeloma Institute
Little Rock, Arkansas, 72205, 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