At a glance
ClinicalIndex Comparison Record- ✓Multiple myeloma stages I-III in response or with stable disease
- ✓Smoldering myeloma with evidence of progressive disease (≥25% increase in M protein, Bence Jones excretion, Hgb ≤10.5 g/dL, frequent infections, hypercalcemia, or rise in serum creatinine)
- ✓Less than 18 months since diagnosis
- ✓Ability to collect minimum 4 x 10^6 CD34+ cells/kg by apheresis
- ✕Waldenstrom's macroglobulinemia
- ✕History of other malignancies within the last 3 years unless in complete remission for ≥2 years (except non-melanoma skin cancer and in situ cervical carcinoma)
- ✕Known hypersensitivity to Filgrastim or E. coli-derived proteins
- ✕Inability to lie supine in full body cast for approximately 30 minutes during TMI treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tandem High-Dose Therapy With Melphalan and Total Marrow Irradiation (TMI) With Peripheral Blood Progenitor Cell Support and Lenalidomide Maintenance in Multiple Myeloma: A Phase I/II Trial
In Brief
A Phase 2 clinical trial evaluating total marrow irradiation, melphalan, and 7 other interventions for Refractory Multiple Myeloma and 4 related conditions. Completed, enrolled 54 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Undergo irradiation
Given IV
Undergo transplantation
Given IV
Correlative studies
Correlative studies
Given IV
Undergo transplantation
Given orally