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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients

Albert Lea, MN, Eau Claire, WI, Rochester, MN

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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Closed for enrollment	View complete study & contact information
Eau Claire, WI	Closed for enrollment
Rochester, MN	Closed for enrollment

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Site IRB:
19-006110
NCT ID:
NCT03937635
Sponsor Protocol Number:
EAA173

SC Versus IV Isatuximab In Combination With Pomalidomide And Dexamethasone In RRMM

Jacksonville, FL
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SC Versus IV Isatuximab In Combination With Pomalidomide And Dexamethasone In RRMM
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  3
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, FL

Closed for enrollment
View complete study & contact information

Print study details
Site IRB:
22-008441

NCT ID:
NCT05405166

Sponsor Protocol Number:
EFC15951
A Study to Understand Why Laying Down May Influence High Blood Pressure in Patient's with a Disease that Causes Problems with the Autonomic Nervous System

Rochester, MN
- See Details
A Study to Understand Why Laying Down May Influence High Blood Pressure in Patient's with a Disease that Causes Problems with the Autonomic Nervous System
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
About this study

The purpose of this research study is to better understand why patients with a disease that causes problems with the autonomic nervous system often have high blood pressure when they lie down. We hope that if we learn more about the cause for this problem, we will be able to treat the problem better in the future.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Closed for enrollment
View complete study & contact information

Print study details
Site IRB:
12-002101

Sponsor Protocol Number:
12-002101

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Albert Lea, MN	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, AZ	Open for enrollment
Eau Claire, WI	Open for enrollment
Jacksonville, FL	Open for enrollment
La Crosse, WI	Open for enrollment
Mankato, MN	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
24-005734
NCT ID:
NCT06630104
Sponsor Protocol Number:
MC230818

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information
Rochester, MN	Closed for enrollment

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information
Rochester, MN	Closed for enrollment

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

See Details

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Prior clinical experience with CD38-targeting antibodies, including daratumumab, establish this molecule as an important therapeutic target in multiple myeloma. CD38 is a type II transmembrane glycoprotein with both ectoenzymatic and signal transductionfunctions. CD38 dimerization is required for its catalytic activity (Desphande et al, 2017).Dimeric CD38 possesses both ADP ribosyl cyclase and cADPR hydrolyase activities; the former generates cyclic ADP ribose (cADPR) from NAD+ and the latter generates ADPR. CD38-mediated cADPR generation enables calcium release from intracellular stores, leading to a variety of cell type-specific physiological outcomes (Schuber and und, 2004; Lee and Aarhus, 1991). A distinct mode of CD38-dependent signal transduction involved in the regulation of proliferation and survival requires interactions with other cell surface molecules (Deshpande et al, 2017; Deaglio et al, 2007; Konopleva et al, 1998). In B- lymphocytes for example, CD38-dependent signal transduction activity utilizes interactions with CD19 and CD31/PECAM-1, the latter of which is the sole identified ligand for CD38 (Deaglio et al, 2007). Importantly, AMG 424 binding to CD38 on target cells results in redirection of T cell mediated cytotoxicity but should not modulate CD38 enzymatic activity or CD38-dependent signal transduction, based on expected serum concentrations in our proposed dosing scheme and significanty reduced binding affinity compared to a monoclonal antibody that does inhibit CD38 activity (Deckert et al., 2014).For this first-in-human study, relapsed/refractory multiple myeloma has been chosen as the indication for clinical investigation of AMG 424 because of the nearly uniform high expression of CD38 on plasma cells observed at the protein level, using flow cytometry (Lin et al, 2004). Although low level CD38 expression is widespread in different tissue types, including hematopoietic cells, plasma cells express CD38 protein at signficantly higher levels than other cell types (Malavasi et al, 2008 and Section 3 of AMG 424 IB).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Closed for enrollment	View complete study & contact information
Jacksonville, FL	Closed for enrollment
Rochester, MN	Closed for enrollment

Print study details

Site IRB:
19-001187
NCT ID:
NCT03445663
Sponsor Protocol Number:
20160445

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Search Results 131-140 of 406 for multiple

A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients

SC Versus IV Isatuximab In Combination With Pomalidomide And Dexamethasone In RRMM

A Study to Understand Why Laying Down May Influence High Blood Pressure in Patient's with a Disease that Causes Problems with the Autonomic Nervous System

MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

A Trial Of TTI-621 For Patients With Hematologic Malignancies And Selected Solid Tumors

White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology

Adherence In Pediatric Multiple Sclerosis

ACP-196 In Combination With Pembrolizumab, For Treatment Of Hematologic Malignancies

Trial Of Sequential Treatment Of Multiple Myeloma With Antibody Therapy

A Study Evaluating AMG 424 In Subjects With Multiple Myeloma

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