Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Vitamin D Deficiency

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Vitamin D

Cholecalciferol

Lenalidomide

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

In this arm, patients will receive the standard lenalidomide dose along with an intensified level of Vitamin D maintenance regimen.

In this arm, patients will receive the standard lenalidomide dose along with a therapeutic level of Vitamin D regimen.

For first three cycles, taken orally once daily for 28 days at 10mg/day dose. After cycle 4, taken orally once daily at 15 mg/day dose

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, will start maintenance therapy with Monthly replacement with 50,000 IU

Vitamin D - Intensified

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels

Vitamin D - Therapeutic

Kelly Jenkins, MSN, RN

GCC Clinical Trials Office

Amany Keruakous, MD

The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive lenalidomide and an intensified regimen of maintenance VitD, and the other arm will receive lenalidomide and a therapeutic regimen of VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.

Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting.

Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment.

VitD3 Supplementation in Patients With Multiple Myeloma

EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE

Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT

Amany Keruakous, MD, MS.

Assistant Professor of Medicine

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Cyclophosphamide

Dexamethasone

Melphalan

Bortezomib

Dexamethasone acetate

Clarithromycin

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Clarithromycin combined with VCD induction therapy

Placebo combined with VCD induction therapy

p.o. clarithromycin 500 mg twice daily for 63 days

Placebo

Three courses of VCD (sc bortezomib 1.3 mg/sqm days 1, 4, 8, 11, iv cyclophosphamide 500 mg/sqm on days 1 and 8, and p.o. dexamethasone 40 mg days 1, 2, 4, 5, 8, 9, 11, 12 in each 21-days course)

VCD induction therapy

Henrik Gregersen, MD

This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.

The survival in younger myeloma patients improved in the nineties with the introduction of high-dose melphalan with autologous stem cell support (HDT). However, all patients will eventually experience relapse after HDT and there is a need for improvement of the response after HDT. The choice of induction treatment before HDT affects the outcome after induction therapy as well as the outcome after HDT.

Clarithromycin is a macrolide antibiotic frequently utilized in the treatment of respiratory tract infections and is often used in patients with known hypersensitivity to beta-lactam antibiotic. Besides antibiotic activity, clarithromycin may exert immunomodulatory and anti-inflammatory effects. The toxicity profile of clarithromycin is favourable and the cost is very low.

Studies on cell lines have shown that clarithromycin attenuates autophagy in myeloma cells and a recent study has demonstrated that treatment with clarithromycin enhanced bortezomib-induced cytotoxicity in myeloma cells. Phase II studies without control groups have indicated that clarithromycin might enhance the effect of the thalidomide and lenalidomide. A case-matched analysis compared patients at one centre receiving clarithromycin, lenalidomide and dexamethasone with an equal number of patients at another centre receiving lenalidomide and dexamethasone. This study indicated a favourable effect of clarithromycin with a higher frequency of complete response, very-good-partial-response or better response and progression-free survival. However, there is a need for controlled studies to determine whether clarithromycin might enhance the effect of other myeloma agents.

This randomized placebo-controlled study will include 160 patients with newly diagnosed multiple myeloma eligible for HDT. The study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma, and is conducted by the Danish Myeloma Study Group (DMSG) at seven clinics in Denmark. The first patient was included in May 2015 and enrolment is expected to continue until October 2016. The study ends when the last included patient has been followed for two months after HDT.

Clarithromycin in Multiple Myeloma Induction Therapy

A Randomized Placebo-controlled Phase II Study of Clarithromycin or Placebo Combined With VCD Induction Therapy Prior to High-dose Melphalan With Stem Cell Support in Patients With Newly Diagnosed Multiple Myeloma

Danish Myeloma Study Group

Henrik Gregersen

Consultant

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The patients will undergo breast reconstruction with an expander prosthesis.

The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis.

100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.

Autologous fat transplantation

breast reconstruction with expander prosthesis.

Expander prosthesis

Inkeri Schultz, PhD

Åsa Edsander-Nord, Docent

Marie Wickman Chantereau, Professor

The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.

Our aims are:

1. To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
2. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.

Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.

Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.

After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.

Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study

Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis.

Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed.

Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients.

Breast Q is a validated questionnaire for quality of life

Karolinska University Hospital

Karolinska Institutet

Adjunct professor

Antipyretics

Analgesics

Dermatologic Agents

Neuroprotective Agents

Anti-Allergic Agents

Central Nervous System Depressants

Amino Acids

Tacrolimus

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Acetaminophen

Cyclosporine

Cyclosporins

Prednisolone

Lenograstim

Mycophenolic Acid

Thymoglobulin

BB 1101

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Diphenhydramine

Promethazine

Mechlorethamine

Antilymphocyte Serum

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

Clotrimazole

Miconazole

Antifungal Agents

Calcineurin Inhibitors

Analgesics, Non-Narcotic

Antibiotics, Antitubercular

Antitubercular Agents

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Glucocorticoids

Hormone Antagonists

Protective Agents

Antineoplastic Agents, Hormonal

Phenylalanine

Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression.

Auto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy.

and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective

Autologous peripheral blood stem cells (auto-PBSC) transplantation

Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.

Allogeneic peripheral blood stem cells (allo-PBSC) transplantation

Filgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis.

Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery.

Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection.

Filgrastim

Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.

Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.

Cyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted.

Total lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion.

Total lymphoid irradiation

ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.

Rabbit anti-thymocyte globulin

MMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression

Mycophenolate Mofetil 250mg

Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion

Solumedrol

Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.

Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.

Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.

Wen-Kai Weng

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients

To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting

Engraftment is assessed as:

* Neutrophil engraftment is \> 0.5 x 10⁹/L after cytopenia
* Platelet engraftment is \> 20 x 10⁹/L after cytopenia

Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)

Complete response rate (CRR) was assessed as all of:

* Negative immunoflixation on the serum and urine
* Disappearance of any soft tissue plasmacytomas
* \< 5% plasma cells in bone marrow

Partial response rate (PRR) was assessed as

* \> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or \< 200 mg/24 hr
* If serum M-protein is not measurable, then \> 50% reduction in the involved serum free light chain
* If involved serum free light chain is not measurable, then \> 50% reduction in the bone marrow plasma cell percentage + \> 50% reduction in the size of any soft tissue plasmacytoma.

To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)

To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)

Stanford University

Assistant Professor of Medicine (Blood and Marrow Transplantation)

A high-dose sequential chemotherapy approach with cyclophosphamide and etoposide followed by granulocyte colony stimulating factor (G-CSF) for collection of peripheral blood progenitor cells as well as for cytoreduction. Total Lymphoid irradiation and anti-thymocyte globulin (TLI/ATG).The preparatory regimens use BCNU and melphalan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
VitD3 Supplementation in Patients With Multiple Myeloma	NCT05846880	Multiple Myelom...	Lenalidomide Vitamin D - Int... Vitamin D - The...	18 Years -	Augusta University
Clarithromycin in Multiple Myeloma Induction Therapy	NCT02573935	Multiple Myelom...	Clarithromycin Placebo VCD induction t...	18 Years -	Aalborg University Hospital
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG	NCT00899847	Transplantation... Transplantation... Multiple Myelom... Blood and Marro...	Autologous peri... Allogeneic peri... Filgrastim Cyclophosphamid... Melphalan Cyclosporine Total lymphoid ... Rabbit anti-thy... Mycophenolate M... Solumedrol Diphenhydramine Acetaminophen Hydrocortisone	18 Years - 75 Years	Stanford University
Clarithromycin in Multiple Myeloma Induction Therapy	NCT02573935	Multiple Myelom...	Clarithromycin Placebo VCD induction t...	18 Years -	Aalborg University Hospital
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma	NCT00733824	Lymphoma, Non-H... Hodgkin Disease	AMD3100 G-CSF Apheresis	18 Years - 75 Years	Washington University School of Medicine
VitD3 Supplementation in Patients With Multiple Myeloma	NCT05846880	Multiple Myelom...	Lenalidomide Vitamin D - Int... Vitamin D - The...	18 Years -	Augusta University

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