SWOG-9321 Melphalan, TBI, and Transplant vs Combo Chemo in Untreated Myeloma
NCT ID: NCT00002548
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
899 participants
INTERVENTIONAL
1994-01-31
2006-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
NCT00002594
SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia
NCT00002665
High-Dose Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma in First Relapse
NCT00002630
Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
NCT00046852
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
NCT00004903
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Compare tumor cytoreduction achieved with VBMCP (vincristine/carmustine/melphalan/cyclophosphamide/prednisone) vs myeloablative melphalan (L-PAM) and total-body irradiation (TBI) with peripheral blood stem cell (PBSC) rescue in symptomatic myeloma patients with stable or responding disease after induction therapy with VAD (vincristine/doxorubicin/dexamethasone) followed by high dose cyclophosphamide plus filgrastim (G-CSF).
* Compare the efficacy of interferon alfa vs no maintenance therapy in those patients achieving at least 75% cytoreduction to either VBMCP or myeloablative therapy with PBSC rescue.
* Assess allogeneic bone marrow transplantation following the same myeloablative regimen of L-PAM/TBI in patients up to age 55 with an HLA-compatible, MLC-nonreactive donor. (As of 8/1/97, permanent partial closure)
* Determine whether myeloablative therapy with PBSC rescue can extend the duration of survival by 33% compared to results from standard dose VBMCP.
* Evaluate the toxic effects and possible long term side effects, including development of myelodysplastic disease and/or acute myeloblastic leukemia, associated with these treatments.
OUTLINE: This is a randomized study. Patients are registered at 5 different points, with stratification occurring at some of these registrations.
* Registration I: Induction I
* Registration II: Induction II. Patients are stratified according to stage of disease (I/II vs IIIA vs IIIB), beta-2 microglobulin at diagnosis (less than 6 micrograms/mL vs at least 6 micrograms/mL), and response to Induction I (75-100% regression vs 50-74% regression vs less than 50% regression vs not applicable).
* Registration III: Patients are randomized to allogeneic bone marrow transplant (BMT) (this arm closed as of 8/1/97) or autologous BMT. Patients are stratified according to treatment received (high dose cyclophosphamide (CTX) and peripheral blood stem cells (PBSC) prior to autologous BMT vs prior to chemotherapy) and beta-2 microglobulin at this registration (less than 2 micrograms/mL vs no greater than 3 micrograms/mL vs unknown).
* Registration IV: Patients are randomized to maintenance therapy or no further therapy. Those patients who are randomized to maintenance therapy are stratified according to treatment (autologous BMT vs chemotherapy vs chemotherapy followed by autologous BMT) and response to treatment (75-99% regression vs complete response).
* Registration V: Patients receive autologous BMT as in registration III. Patients are stratified according to prior best response (50% or better vs less than 50% vs not applicable), duration of chemotherapy (at least 6 months vs less than 6 months), and progression after therapy (chemotherapy vs interferon alfa vs observation).
* Induction I: Patients receive vincristine IV and doxorubicin IV by continuous infusion on days 1-4 and dexamethasone IV or orally on days 1-4, 9-12, and 17-20. Treatment repeats every 5 weeks for up to 4 courses. Patients with progressive disease after 2 courses proceed to PBSC stimulation/harvest.
Allogeneic BMT arm is permanently closed as of 8/1/97.
* Autologous BMT: Therapy begins 4-8 weeks following high dose cyclophosphamide. Patients receive melphalan IV over 1 hour on day -5 and total body irradiation twice a day on days -4 to -1. PBSC are reinfused on day 0. G-CSF SQ is administered beginning on day 1 until blood counts recover.
* Chemotherapy: Patients receive vincristine IV, carmustine IV, and cyclophosphamide IV on day 1, oral melphalan on days 1-4, and oral prednisone on days 1-7. Treatment repeats every 5 weeks for at least 12 months.
Patients who have at least a 75% response to autologous BMT or chemotherapy are randomized to maintenance vs no further therapy. Patients who progress on chemotherapy proceed to autologous BMT (registration V).
* Maintenance therapy: Therapy begins between 5 and 12 weeks after PBSC rescue. Patients receive interferon alfa SQ three times a week. Treatment continues for 4 years in the absence of disease progression or unacceptable toxicity.
Patients who progress on chemotherapy undergo an autologous BMT within 8 weeks after the last course of chemotherapy.
Patients who are randomized to receive no further therapy are observed for 1 year.
PROJECTED ACCRUAL: A total of 500 patients will be randomized over about 4 years to autologous transplantation vs chemotherapy as follows: about 250 patients/year will be accrued for induction of whom 200 will achieve at least stable disease, 125 will be randomized, and 15 will have a suitable donor for allogeneic transplant (as of 8/1/97, allogeneic arm of study is closed). Approximately 300 patients are expected to be randomized to maintenance vs no further therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HDCTX and PBSC
High dose chemotherapy with peripheral blood stem cells
High dose chemotherapy with peripheral blood stem cells IND (q 5 weeks): vincristine 0.5 mg/d cont IV D1-4; adriamycin 10mg/m2/d cont IV D1-4; dex 40 mg/d PO or IVPB D1-4, 9-12, 17-20
2nd Reg: cyclophosphamide 1.5g/m2 IV over 1 hr every 3 hrs x 3 (4.5g/m2 total); MESNA 4.5 g/m2 24 hr IV start with cyclo; GCSF 0.25 mg/m2/d SQ; PBSC collection
Chemo: vincristine 1.2 mg/m2 IV D1, BCNU 20 mg/m2 IV D1, melphalan 8 mg/m2 PO D1-4, cyclophosphamide 400 mg/m2 IV D1, prednisone 40 mg/m2 PO D1-7
doxorubicin hydrochloride
10 mg/m2/day continuous 1 - 4 q 5 weeks
melphalan
140 mg/m2 is given IV within 30 minutes of constitution on Day -5
prednisone
40 mg/m2 PO days 1-7 q 35 days
vincristine sulfate
0.5 mg/day continuous 1 - 4 q 5 weeks
peripheral blood stem cell transplantation
day 0
HDCTX with PBSC and Autologous BMT
High dose chemotherapy with peripheral blood stem cells and autologous bone marrow transplant
High dose chemotherapy with peripheral blood stem cells and autologous bone marrow transplant
High dose chemotherapy with peripheral blood stem cells IND (q 5 weeks): vincristine 0.5 mg/d cont IV D1-4; adriamycin 10mg/m2/d cont IV D1-4; dex 40 mg/d PO or IVPB D1-4, 9-12, 17-20
2nd Reg: cyclophosphamide 1.5g/m2 IV over 1 hr every 3 hrs x 3 (4.5g/m2 total); MESNA 4.5 g/m2 24 hr IV start with cyclo; GCSF 0.25 mg/m2/d SQ; PBSC collection
Auto Trans: Mel 140mg/m2 IV D-5; TBI 150cGy D-4, -3, -2, -1; infusion D0
carmustine
20 mg/m2 I.V. day 1 q 35 days
cyclophosphamide
1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)
dexamethasone
40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks
doxorubicin hydrochloride
10 mg/m2/day continuous 1 - 4 q 5 weeks
melphalan
140 mg/m2 is given IV within 30 minutes of constitution on Day -5
prednisone
40 mg/m2 PO days 1-7 q 35 days
allogeneic bone marrow transplantation
day 0
autologous bone marrow transplantation
day 0
peripheral blood stem cell transplantation
day 0
radiation therapy
administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)
HDCTX with PBSC and interferon
High dose chemotherapy with peripheral blood stem cells and interferon
Experimental: HDCTX with PBSC and interferon High dose chemotherapy with peripheral blood stem cells and interferon
High dose chemotherapy with peripheral blood stem cells IND (q 5 weeks): vincristine 0.5 mg/d cont IV D1-4; adriamycin 10mg/m2/d cont IV D1-4; dex 40 mg/d PO or IVPB D1-4, 9-12, 17-20
2nd Reg: cyclophosphamide 1.5g/m2 IV over 1 hr every 3 hrs x 3 (4.5g/m2 total); MESNA 4.5 g/m2 24 hr IV start with cyclo; GCSF 0.25 mg/m2/d SQ; PBSC collection
Chemo: vincristine 1.2 mg/m2 IV D1, BCNU 20 mg/m2 IV D1, melphalan 8 mg/m2 PO D1-4, cyclophosphamide 400 mg/m2 IV D1, prednisone 40 mg/m2 PO D1-7
IFN: IFN 3 million units/m2 MWF SQ
recombinant interferon alfa
3 million units/m2 SQ Monday-Wednesday
-Friday (3 times a week)
doxorubicin hydrochloride
10 mg/m2/day continuous 1 - 4 q 5 weeks
melphalan
140 mg/m2 is given IV within 30 minutes of constitution on Day -5
prednisone
40 mg/m2 PO days 1-7 q 35 days
vincristine sulfate
0.5 mg/day continuous 1 - 4 q 5 weeks
peripheral blood stem cell transplantation
day 0
HDCTX with PBSC and transplant plus IFN
High dose chemotherapy with peripheral blood stem cells and autologous bone marrow transplant plus alpha interferon
Experimental: HDCTX with PBSC and transplant plus IFN High dose chemotherapy with peripheral blood stem cells and autologous bone marrow transplant plus alpha interferon
High dose chemotherapy with peripheral blood stem cells IND (q 5 weeks): vincristine 0.5 mg/d cont IV D1-4; adriamycin 10mg/m2/d cont IV D1-4; dex 40 mg/d PO or IVPB D1-4, 9-12, 17-20
2nd Reg: cyclophosphamide 1.5g/m2 IV over 1 hr every 3 hrs x 3 (4.5g/m2 total); MESNA 4.5 g/m2 24 hr IV start with cyclo; GCSF 0.25 mg/m2/d SQ; PBSC collection
Trans: Mel 140mg/m2 IV D-5; TBI 150cGy D-4, -3, -2, -1; infusion D0
IFN: 3 million units/m2 MWF SQ
recombinant interferon alfa
3 million units/m2 SQ Monday-Wednesday
-Friday (3 times a week)
carmustine
20 mg/m2 I.V. day 1 q 35 days
cyclophosphamide
1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)
dexamethasone
40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks
doxorubicin hydrochloride
10 mg/m2/day continuous 1 - 4 q 5 weeks
melphalan
140 mg/m2 is given IV within 30 minutes of constitution on Day -5
prednisone
40 mg/m2 PO days 1-7 q 35 days
autologous bone marrow transplantation
day 0
peripheral blood stem cell transplantation
day 0
radiation therapy
administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
recombinant interferon alfa
3 million units/m2 SQ Monday-Wednesday
-Friday (3 times a week)
carmustine
20 mg/m2 I.V. day 1 q 35 days
cyclophosphamide
1.5 g/m2 in 100 ml of D5W, IV intravenously over 1 hour every 3 hour x 3 (total dose 4.5 g/m2)
dexamethasone
40 mg/day PO or IVPB days 1-4, 9-12, 17-20 q 5 weeks
doxorubicin hydrochloride
10 mg/m2/day continuous 1 - 4 q 5 weeks
melphalan
140 mg/m2 is given IV within 30 minutes of constitution on Day -5
prednisone
40 mg/m2 PO days 1-7 q 35 days
vincristine sulfate
0.5 mg/day continuous 1 - 4 q 5 weeks
allogeneic bone marrow transplantation
day 0
autologous bone marrow transplantation
day 0
peripheral blood stem cell transplantation
day 0
radiation therapy
administered in fractionated doses of 150 cGy, 6 - 10 hours apart bid, on Days -4, -3, -2, and -1 (Total 1,200 cGy)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* HLA followed by DR and MLC testing required
* Renal failure, even on dialysis, eligible provided:
* Cause is attributed to myeloma (Bence-Jones protein or hypercalcemia)
* Duration does not exceed 2 months
* If medically appropriate, the following conditions should be treated prior to registration:
* Pathologic fractures
* Pneumonia at diagnosis
* Hyperviscosity with shortness of breath
PATIENT CHARACTERISTICS:
Age:
* 70 and under
Performance status:
* SWOG 0-2 (SWOG 3 or 4 based solely on bone pain allowed)
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* See Disease Characteristics
Cardiovascular:
* Normal ejection fraction by ECHO or MUGA
* No myocardial infarction within 6 months
* No unstable angina
* No difficult to control congestive heart failure
* No uncontrolled hypertension
* No difficult to control arrhythmias
* No history of chronic cerebral vascular accident
Pulmonary:
* No history of chronic obstructive or restrictive pulmonary disease
* Pulmonary function studies and DLCO at least 50% of predicted except for demonstrated myeloma involvement on bronchoscopy and/or open lung biopsy
Other:
* No uncontrolled diabetes
* No significant comorbid medical condition
* No uncontrolled, life-threatening infection
* No prior malignancy within 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No prior malignancy treated with cytotoxic drugs used on this protocol
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy except local radiotherapy provided the following cumulative dose limits for prior dose plus potential TBI dose on protocol are not exceeded:
* Less than 5,000 cGy to bone
* Less than 4,000 cGy to mediastinum, heart, small bowel, brain, and spinal cord
* Less than 2,000 cGy to the liver
* Less than 1,500 cGy to the kidney and lungs
Surgery:
* Not specified
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bart Barlogie, MD
Role: STUDY_CHAIR
University of Arkansas
Kenneth C. Anderson, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Robert A. Kyle, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van Ness BG, Ramos C, Kumar V, et al.: Analytical approaches for the BOAC SNP panel association with progression free survival in myeloma. [Abstract] Blood 112 (11): A-2715, 2008.
Crowley JJ, McCoy J, LeBlanc M, et al.: Extreme regression: a statistical technique for finding good or poor prognostic groups, illustrated using myeloma patient data from Intergroup trial S9321. [Abstract] Blood 104 (11): A-5202, 2004.
Greipp PR, Kumar S, Blood EA, et al.: A simple classification to identify poor-risk untreated myeloma. [Abstract] Blood 100 (11 Pt 1): A-2351, 598a, 2002.
Tian E, Bumm K, Xiao Y, et al.: A protocol for triple color interphase FISH on archived bone marrow biopsies from myeloma prepared with precipitating fixatives. [Abstract] Blood 96 (11 pt 1): A-665, 155a, 2000.
Rajkumar V, Leong T, Fonseca R, et al.: Bone marrow angiogenesis has prognostic value in multiple myeloma: an Eastern Cooperative Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A68, 19a, 1999.
Rimsza LM, Campbell K, Dalton WS, Salmon S, Willcox G, Grogan TM. The major vault protein (MVP), a new multidrug resistance associated protein, is frequently expressed in multiple myeloma. Leuk Lymphoma. 1999 Jul;34(3-4):315-24. doi: 10.3109/10428199909050956.
Barlogie B, Kyle RA, Anderson KC, Greipp PR, Lazarus HM, Hurd DD, McCoy J, Moore DF Jr, Dakhil SR, Lanier KS, Chapman RA, Cromer JN, Salmon SE, Durie B, Crowley JC. Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase III US Intergroup Trial S9321. J Clin Oncol. 2006 Feb 20;24(6):929-36. doi: 10.1200/JCO.2005.04.5807. Epub 2006 Jan 23.
Van Ness BG, Crowley JC, Ramos C, et al.: SNP genotypes show association with common toxicities during both VAD induction and high dose melphalan with autologous transplant support in intergroup trial S9321 for myeloma: from the Bank on a Cure. [Abstract] Blood 106 (11): A-3488, 2005.
Crowley J, Fonseca R, Greipp P, et al.: Comparable survival in newly diagnosed multiple myeloma (MM) after VAD induction with high dose therapy using melphalan 140mg/m2 + TBI 12 Gy (MEL+TBI) versus standard therapy with VBMCP and no benefit from interferon (IFN) maintenance: final clinical results of intergroup trial S9321 in the context of IFM 90 and MRC VII trials. [Abstract] Blood 104 (11): A-539, 2004.
Santana-Davila R, Crowley J, Durie B, et al.: Genetic polymorphisms associated with clinical outcome in the intergroup trial S9321, comparing high dose therapy with standard dose therapy for myelomaon, on behalf of ECOG, SWOG, CALGB, and the Bank on a Cure. [Abstract] Blood 104 (11): A-1495, 2004.
Lee CK, McCoy J, Anderson KC, et al.: Long-term follow-up of previously untreated symptomatic myeloma patients treated with myeloablative therapy and sibling-matched allogeneic transplantation of the SWOG study 9321. [Abstract] Blood 100 (11 pt 1): A-1644, 2002.
Greipp PR, Jacobson JL, Crowley JJ, et al.: BETA 2 microglobulin (beta 2M) and plasma cell labeling index (PCLI) constitute a strong prognostic index in the SWOG intergroup transplant trial S9321: observations on gender and age. [Abstract] Blood 96 (11 pt 1): A-653, 152a, 2000.
Desika R, Salmon S, Anderson K, et al.: Planned melphalan-total body irradiation (MEL-TBI) - based allogeneic transplantation for multiple myeloma (MM) up to age 55: an intergroup experience (CALGB, ECOG and SWOG) under the auspices of the Southwest Oncology Group (SWOG 9321). [Abstract] Blood 94 (10 Pt 1): A-1546, 346a, 1999.
Usmani SZ, Heuck C, Mitchell A, Szymonifka J, Nair B, Hoering A, Alsayed Y, Waheed S, Haider S, Restrepo A, Van Rhee F, Crowley J, Barlogie B. Extramedullary disease portends poor prognosis in multiple myeloma and is over-represented in high-risk disease even in the era of novel agents. Haematologica. 2012 Nov;97(11):1761-7. doi: 10.3324/haematol.2012.065698. Epub 2012 Jun 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SWOG-9321
Identifier Type: OTHER
Identifier Source: secondary_id
CLB-9312
Identifier Type: OTHER
Identifier Source: secondary_id
E-S9321
Identifier Type: OTHER
Identifier Source: secondary_id
INT-0141
Identifier Type: OTHER
Identifier Source: secondary_id
SWOG-9321
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.