New chemo cocktail aims to outsmart aggressive myeloma
NCT ID NCT00869232
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a combination of eight chemotherapy drugs given in lower doses and shorter cycles to people with high-risk multiple myeloma. The goal is to prevent myeloma cells from regrowing between treatments, leading to longer remissions and better survival. The study enrolls 90 newly diagnosed patients with high-risk features.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of chemotherapy drugs: Velcade, melphalan, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide
- What this could lead to
- If it works, this approach could lead to longer remissions and better survival for people with high-risk multiple myeloma.
- What could go wrong
- This is a phase II trial with only 90 participants, so results may not apply to everyone. The intensive chemo regimen also carries risks like infection and organ damage.
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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90 people
The number who actually took part.
- Start date
-
Oct 2008
- Expected to finish
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Oct 2028
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: * Patients must have newly diagnosed active MM requiring treatment. Patients with previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy. * Patients must be either untreated o have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation. * Patients must have high-risk disease, as defined by any one of the following: * GEP risk score of \> or = 0.66 or * LDH \> or = 360 U/L Rule out hemolysis, infection an contact PI for clarification * Zubrod \< or = 2, unless solely due to symptoms of MM-related bone disease. * Patients must have a platelet count of \> or = 50,000/uL, unless lower levels are explained by extensive bone marrow plasmacytosis. * Patients must be at least 18 years of age and not older than 75 years of age at the time of registration. * Participants must have preserved renal function as defined by a serum creatinine level of \< 3 mg/dL. * Participants must have an ejection fraction by ECHO or MUGA scan \> or = 45% * Patients must have adequate pulmonary function studies \> or = 50% of predicted on mechanical aspects (FEV squared, FVC, etc) and diffusion capacity (DLCO) \> or = 50% of predicted. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted if the principle investigator documents that the patient is a candidate for high dose therapy. * Patients must have signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB. Exclusion Criteria: * Does not have high-risk disease * Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. * 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. * Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Subjects 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
Little Rock, Arkansas, 72205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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