New chemo rhythm aims to outsmart myeloma relapse
NCT ID NCT00871013
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a new way of giving chemotherapy to people with high-risk multiple myeloma who have already had some treatment. Instead of high doses with long breaks, researchers give lower doses in shorter cycles to prevent cancer cells from regrowing. The goal is to improve remission rates and survival at two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melphalan, Bortezomib (Velcade), Thalidomide
- What this could lead to
- If successful, this approach could extend remission and survival for high-risk myeloma patients who have already received treatment.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The lower-dose strategy may not improve outcomes, and side effects from the drugs are possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Mar 2009
- Expected to finish
-
Dec 2027
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
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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 with symptomatic multiple myeloma (MM), with at least one prior line of chemotherapy or newly diagnosed without any prior therapy. * Zebroid ≤ 2, unless solely due to symptoms of MM-related bone disease (Appendix 4). * Patients must be at least 18 years of age and not older than 75 years of age at the time of registration. * Patient must not have had a prior auto- or allotransplant. * Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study. * 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 prior to enrollment. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70. * Ejection fraction by ECHO or MUGA must be ≥ 40% and must be performed within 60 days prior to enrollment, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated. * 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 be able to receive full doses of Mel-VRD-PACE, in the opinion of the treating investigator, with the exception that patients with creatinine clearance 30-50 ml/min will receive only 50% of the cisplatin dose. Exclusion Criteria: * Fever or active infection requiring intravenous antibiotic, defined as fever or antibiotics within 72 hours from registration. * Severe renal dysfunction, defined as a creatinine \> 3mg/dl or a creatinine clearance of \< 30ml/min. * Significant neurotoxicity, defined as grade ≥ 3 neurotoxicity per NCI Common Toxicity Criteria (See Appendix). * Platelet count \< 30,000/mm3, and ANC \< 1,000/μl * POEMS Syndrome: (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes * Clinically significant hepatic dysfunction as noted by direct bilirubin or AST \>3 times the upper normal limit or clinically significant concurrent hepatitis. * New York Heart Association (NYHA) Class III or Class IV heart failure (Appendix 4). * Recent (≤ 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. * Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias. * 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. * Prior cumulative total of Adriamycin exposure \>450 mg/m2. * Prior exposure to thalidomide which resulted in severe toxicity requiring drug discontinuation. * Prior exposure to Revlimid which resulted in severe toxicity requiring drug discontinuation * Hypersensitivity to boron, or Mannitol. Prior exposure to bortezomib which resulted in severe toxicity requiring drug discontinuation. * 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.
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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
-
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
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