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Rao M, Lamont JL, Chan J, et al. Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 73 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Sep. (Future Research Needs Papers, No. 23.)

Cover of Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias: Future Research Needs

Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 73 [Internet].

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Appendix BLists of Ongoing Studies

Ongoing Research on the SFLC Assay in ClinicalTrials.gov as of July 7, 2012*

ClinicalTrials.gov NumberTitleRecruitmentPatient PopulationEnrollment
NCT00089167Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic AmyloidosisCompletedMM and plasma cell neoplasmNR
NCT00301275Assessing Free Immunoglobulin Light Chains in Patients With MyelomaCompletedMMNR
NCT00416897Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney FailureRecruitingMM and plasma cell neoplasm280
NCT00478075Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple MyelomaCompletedMM and plasma cell neoplasm50
NCT00499577Stem Cell Transplant, Chemotherapy, and Biological Therapy in Treating Patients With High-Risk or Refractory Multiple MyelomaCompletedMM and plasma cell neoplasm56
NCT00621400Lenalidomide in Combination With Melphalan and Dexamethasone in Newly-diagnosed Light-chain (AL)-AmyloidosisCompletedAmyloidosis27
NCT00910078Serum Free Light Change in Multiple MyelomaCompletedMMNR
NCT00972712Protocol of the Combination of Bortezomib and Tipifarnib for Relapsed or Refractory Multiple MyelomaActive, not recruitingMM35
NCT00637767High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell TransplantRecruitingMM and plasma cell neoplasm90
NCT00681044High-Dose Melphalan and Stem Cell Transplant in Treating Patients With Immunoglobulin Deposition Disease or Light-Chain Deposition DiseaseRecruitingMM and plasma cell neoplasm30
NCT00821301Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple MyelomaRecruitingMM30
NCT00881920Autologous T Lymphocytes Engrafted With a Chimeric Antigen Receptor Targeting the Kappa Light ChainRecruitingLymphoma
Myeloma
Leukemia
18
NCT01084837Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal FailureRecruitingMM60
NCT01194791Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly DiagnosedRecruitingPrimary systemic amyloidosis30
NCT01208818Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast NephropathyRecruitingChronic renal failure with uremic nephropathy284
NCT01277016A Trial for Systemic Light-chain (AL) AmyloidosisRecruitingAL amyloidosis110
NCT01383759Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisRecruitingLight chain and heavy chain deposition disease
Monoclonal Immunoglobulin deposition disease
Amyloidosis
35
NCT01423344Clinical Evaluation of the Serum Free Light Chain AnalysisRecruitingMM30
NCT01109004**Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)RecruitingMM750
NCT00120263Trial of Plasma Exchange for Acute Renal Failure at the Onset of MyelomaCompletedMM
Acute Renal
Failure
92
NCT00135187Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple MyelomaCompletedMM30
NCT00344526Intensive Versus Conventional Treatment in Patients With Primary AmyloidosisCompletedPrimary systemic amyloidosis100
NCT00726466Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular DegenerationWithdrawnAMD
CNV
10
NCT00787969Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell LymphomaActive, not recruitingLymphoma74
NCT00981097Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin LymphomaRecruitingLymphoma
Nonneoplastic
Condition
50
NCT01067313Continuous Hemodialysis With an Enhanced Middle Molecule Clearance MembraneCompletedSeptic Shock24
NCT01237054Imaging in MGUS, SMM and MMCompletedMM
Smoldering MM
MGUS
31
NCT01308073Stability of Middle Molecule ClearanceRecruitingContinuous
Hemodialysis
15
NCT01541527Non Neutralizing Antibodies: Prevalence and CharacterizationRecruitingHemophilia A300

Abbreviations: AL amyloidosis = systemic amyloidosis in which amyloid [A] proteins derived from immunoglobulin light chains [L] are deposited in tissue, AMD = Age-Related Macular Degeneration, CNV = choroidal neovascularization, MGUS = Monoclonal Gammopathy of Undetermined Significance, MM = multiple myeloma, NR = not reported.

*

Search terms were as follows: [Immunoglobulin Light Chain* OR monoclonal light chain* OR serum free light chain* OR immunoglobulin-free light chain* OR Bence Jones protein*]. We also conducted a search of published randomized controlled trials but did not find any of interest that were published after the CER was completed.

**

Identified by a reviewer of the SFLC comparative effectiveness review rather than through this ClinicalTrials.gov search. After adding this, because it was not captured in search, we ran an alternative search strategy crossing four new terms (Multiple myeloma* OR Plasma cell neoplasms* OR Amyloidosis* OR Paraproteinemias*) with the original terms (Immunoglobulin Light Chain* OR monoclonal light chain* OR serum free light chain* OR immunoglobulin-free light chain* OR Bence Jones protein*). This alternative search yielded only 23 studies—less than the updated original and still missing the NCT01109004 study. Thus we report the results of our original search in this table.

Bookshelf ID: NBK137797

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