Can a lighter chemo cocktail tame myeloma without the brutal side effects?
NCT ID NCT00734877
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether a less intense version of a standard chemotherapy regimen can reduce side effects by half while still controlling low-risk multiple myeloma in adults 65 and under. Participants receive a combination of drugs, a stem cell transplant, and three years of maintenance therapy. The study originally compared two regimens, but the milder arm has been closed, and all new participants now receive the standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination chemotherapy (melphalan, bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, etoposide) followed by stem cell transplant and maintenance therapy
- What this could lead to
- If successful, this could offer a less toxic treatment option for low-risk multiple myeloma that still controls the disease effectively.
- What could go wrong
- This is an early-stage comparison of two intensive regimens; the reduced-toxicity arm has already been closed. The trial is not designed to cure, and long-term side effects from chemotherapy and transplant remain significant.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
382 people
The number who actually took part.
- Started
-
Jul 2008
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. * Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation. * Participants must have low-risk disease, as defined by any of the following: * GEP risk score of \< 0.66 * lack of GEP-defined TP53 deletion (Affymetrix signal \<727) * No metaphase based abnormalities of 1q or 1p * LDH \<360 U/L Rule out hemolysis, infection, and contact PI for Clarification * Zubrod ≤ 2, unless solely due to symptoms of MM-related bone disease. * 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 ≥ 40% * Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) \> 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 principal 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: * High risk disease defined by high-risk gene array features as determined by any of the following: * GEP risk score of ≥ 0.66 or * Presence of GEP-defined TP53 deletion, or * Presence of abnormalities of chromosome 1 (amp1q, del 1p). * 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. * Platelet count \< 30 x 109/L, unless myeloma-related. * Grade \> 2 peripheral neuropathy. * Hypersensitivity to bortezomib, boron, or mannitol. * 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 * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval or if the malignancy is considered much less life threatening than the myeloma. * Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Low risk multiple myeloma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
Little Rock, Arkansas, 72205, 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?