CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Am… (NCT00558896) | Clinical Trial Compass
CompletedPhase 2
CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
United States378 participantsStarted 2007-11
Plain-language summary
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Symptomatic multiple myeloma
* Previously treated disease meeting one of the following criteria:
* Have light-chain amyloidosis that has been treated with at least one prior regimen
* Symptomatic (relapsed or refractory) multiple myeloma
* Patients must have received 1-3 treatment regimens
* Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen
* Measurable disease, as defined by 1 of the following:
* Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
* More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
* Serum immunoglobulin free light chain (FLC) \> 10 mg/dL and an abnormal FLC ratio
* Measurable soft tissue plasmacytoma, not previously irradiated
* More than 30% plasma cells in bone marrow
* At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index
* No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)
* No smoldering myeloma (not applicable for patients with amyloid)
PATIENT CHARACTERISTICS:
* ECOG performance status 0, 1, or 2
* ANC ≥ 1,000/μL
* Platelet count ≥ 75,000/μL
* Creatinine ≤ 2.5 mg/dL
* Not pregnant or nursing
* Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug
* Negative pregnancy test
* Fertile female patients must use two reliable forms of contracept…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)