Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing … (NCT00112827) | Clinical Trial Compass
CompletedPhase 1/2
Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma
United States54 participantsStarted 2004-11
Plain-language summary
RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment choice for destroying myeloma cells, especially when given at high (bone marrow ablative) doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT) given after either melphalan or following TMI (aimed at the bone marrow containing areas of the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an effective agent on its own right for the treatment of myeloma, has been shown to further enhance the beneficial effects of autologous stem cell transplants when given as maintenance therapy.
PURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy. The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific emphasis on assessing complete and very good partial response rate conversions, progression-free and overall survival, and safety/feasibility of delivering the planned treatment regimen.
Who can participate
Age range
70 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.
Criteria
* Patients with multiple myeloma (stages I-III) will be eligible if they are either in response, or have stable disease
* Patients with smoldering myeloma are eligible if there is evidence of progressive disease requiring therapy (\>= 25% increase in M protein levels or Bence Jones excretion; Hgb =\< 10.5 g/dl; frequent infections; hypercalcemia; rise in serum creatinine above normal on two separate occasion)
* Patients with non-quantifiable monoclonal proteins are eligible provided they meet other criteria for multiple myeloma, or smoldering myeloma, and they have evaluable or measurable disease by other (radiographic) means
* Unlimited prior chemotherapy regimens allowed
* KPS \>= 70%
* Patients with Waldenstrom's macroglobulinemia are not eligible
* Less than 18 months since diagnosis
* No contraindication to the collection of a minimum of 4 x 10\^6 CD34+ cells/kg by apheresis
* All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
* Adequate hepatic function as demonstrated by bilirubin, =\< 1.5 mg/dl, and SGOT and SGPT \< 2.5 x upper limits of normal
* Adequate renal function as demonstrated by: creatinine of measured or calculated creatinine clearance of \> 50 cc/min
* Absolute neutrophil count of \> 1000/ul, platelet count of \> 100,000/ul
* Cardiac ejection fraction \>= 50% by MUGA scan and/or by echocardiogram
* Adequate pulmonary function as demonstrated by FEV1 \> 60% and DLCO \> 50% of predict…
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
Maximum Tolerated Dose (MTD)
Timeframe: 8 weeks from start of treatment, up to 2 years
2
Number of Subjects With Response
Timeframe: Evaluated after each course until completion of treatment.
3
Overall Survival
Timeframe: From date of treatment until the date of death from any cause, assessed up to 14 years