Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Antipyretics

Analgesics

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Respiratory System Agents

Dexamethasone

Acetaminophen

Lenalidomide

Bortezomib

Daratumumab

Dexamethasone acetate

Diphenhydramine

Promethazine

Montelukast

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Analgesics, Non-Narcotic

Anti-Asthmatic Agents

Leukotriene Antagonists

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Participants in this group will receive Bortezomib, Lenalidomide and Dexamethasone on a 21 day treatment cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.

Participants in this group will receive Carfilzomib, Lenalidomide and Dexamethasone on a 28 day cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.

Participants in this group will receive Carfilzomib, Lenalidomide, Dexamethasone with Daratumumab, Acetaminophen, Diphenhydramine and Montelukast on a 28 day cycle. Participants achieving a PR or better at the end of 4 cycles will continue to receive a total of 8 cycles of combination therapy. Participants with less than PR after completing 4 cycles will go off study therapy. After 8 cycles of therapy, participants who are MRD positive will have the option to receive an ASCT if stem cells were able to be extracted, before initiating maintenance therapy with Lenalidomide for up to 2 years, and patients who are MRD negative will go directly on to receive maintenance therapy with Lenalidomide for up to 2 years.

1.3 mg/m2 administered Subcutaneous (SC) or intravenous (IV) on days 1, 4, 8 and 11 of a 21 day treatment cycle for participants randomized to Arm A.

20 mg or 40 mg per dose administered by mouth (PO) or IV.

Participants randomized in Arm A:

20 mg/dose on days 1, 4, 8 and 11 on a 21 day treatment cycle;

Participants randomized in Arm B:

Cycles 1 through 8 - 40mg/dose on days 1, 8 and 15 on a 28-day cycle

Participants randomized in Arm C:

Cycle 1-2 - 40 mg/dose on days 1, 8, 15 and 22 on a 28-day cycle; Cycles 3-8 - 40mg/dose on Days 1, 8, 15 on a 28-day cycle;

10 or 25 mg/day capsules administered PO.

Participants randomized in Arm A:

25 mg/day capsules on Days 1 through 14 of a 21 day cycle.;

Participants randomized in Arm B:

Cycles 1 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;

Participants randomized in Arm C:

Cycles 1 - 25 mg/day capsules on Days 2 through 21 of a 28 day cycle; Cycles 2 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;

Maintenance Therapy:

10 mg capsules on Days 1 through 21 on a 28 days cycle.

650 mg administered PO.

Participants randomized to Arm C:

Cycles 1 through 8 - 650 mg administered on Days 1, 8 and 15.

25 mg administered via IV

Participants randomized to Arm C:

Cycles 1 through 8 - 25 mg administered on Days 1, 8 and 15.

10 mg administered PO to participants randomized to Arm C prior to the first 4 doses of Daratumumab.

20 mg or 56 mg/m2 per dose administered via IV.

Participants randomized to Arm B:

Cycle 1 - 20 mg/m2 per dose on Day 1 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle;

Participants randomized to Arm C:

Cycle 1 - 20 mg/m2 per dose on Day 2 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle

Carfilzomib

16 mg/kg administered via IV or 1800 mg SC, per treating physician discretion.

Participants randomized to Arm C:

Cycles 1 though 2 - 16 mg/kg IV or 1800 mg SC on days 1, 8, 15, and 22 of a 28 day cycle; Cycles 3 through 6- 16 mg/kg IV or 1800 mg SC on days 1 and 15 of a 28 day cycle; Cycles 7 through 8 - 16 mg/kg IV or 1800 mg SC on day 1 of a 28 day cycle

Participants who are MRD positive at the conclusion of 8 cycles of study treatment, and were able to have their stem cells that were extracted, will receive ASCT from participants' bone marrow samples.

Autologous Stem Cell Transplant (ASCT)

Philip Arlen

Philip Arlen, MD

Carl Landgren, MD

Ken Shain, MD

Ariffa Kariapper

Jens Hillengass, MD

Aisha Hashmi

Thomas Jandl, MD

Elisabet Manasanch, MD

Douglas Sborov, MD

This study is being done to find out whether carfilzomib, lenalidomide, and dexamethasone (KRD) or KRD and Daratumumab (KRD+DARA) might be safer and more effective ways of controlling multiple myeloma than the stand or care treatment, which is lenalidomide, bortezomib, and dexamethasone (VRD).

Per protocol amendment version 4.0 (May 23, 2022), Arm A will be closed and no additional participants will be enrolled in this arm.

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

MRD will be assessed by the MRD scale ranging from 10 (increased disease detection) to -5 (less to no disease detection) after 8 cycles of therapy.

Overall survival is defined as the time from date of randomization to death from any cause

PFS is defined as time from date of randomization to time of progression or death, whichever occurs first.

EFS is defined as time from date of randomization to the time of 1) achieving a PR or less with the first four cycles of therapy, 2) transplant, 3) progression, or 4) death, whichever occurs first.

Rate of Response will be reported as the percentage of participants achieving a response of: a) Partial Response (PR) or better, b) Very Good Partial Response (VGPR) or better and c) Complete Response (CR) and Stringent Complete Response (sCR). Responses will be evaluated from participant serum, urine and bone marrow samples.

MRD will be evaluated from bone marrow samples.

Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

MRD Negativity using bone marrow and blood samples

Amgen

Janssen Pharmaceuticals

University of Miami

Prior to Iber-KDd combination therapy, participants will receive Acetaminophen, Diphenhydramine and Montelukast therapy per protocol. Participants will receive up to eight (8) 28-day cycles of combination Iberdomide (I), Carfilzomib (K), Daratumumab (D), and Dexamethasone (d) (Iber-KDd) therapy. Participants will receive Iber-KDd combination therapy for approximately 8 months. In the absence of disease progression, participants will continue on to Iber monotherapy. Participants with disease progression will discontinue study therapy but will continue to be followed for up to three (3) years after conclusion of Iber-KDd combination therapy.

After completion of Iber-KDd combination therapy, and In the absence of disease progression, participants will then receive up to twelve (12) 28-day cycles of Iberdomide (Iber) monotherapy. Participants will receive Iber monotherapy for up to 12 months or until disease progression. Participants will be followed for up to three (3) years after conclusion of Iber monotherapy. Total study participation is up to five (5) years.

Participants will receive Iberdomide (Iber) therapy orally (PO) in capsules as follows:

* Combination therapy: Cycles 1 to 8: 1 mg per day\*, Days 1 to 21 every 28 days.
* Monotherapy: Cycles 9 to 20: 1 mg per day\*, Days 1 to 21 every 28 days.

(\*) The first 6 patients will begin at 1 mg/day as lead-in with option to increase to 1.3 mg with dose-escalation cohort after two (2) cycles tolerated therapy

Iberdomide

Participants will receive Carfilzomib (K) therapy intravenously (IV) as follows:

* Cycle 1: 20 mg/m2 per dose on Day 1; 56 mg/m2 per dose on Days 8 and 15
* Cycles 2 to 8: 56 mg/m2 per dose on Days 1, 8, and 15.

Participants will receive Daratumumab (D) therapy subcutaneously (SC) or intravenously (IV) as follows:

* Cycles 1 and 2: 1800 mg SC or 16 mg/kg IV on Days 1, 8, 15, and 22
* Cycles 3 through 6: 1800 mg SC or 16 mg/kg IV on Days 1 and 15
* Cycles 7 and 8: 1800 mg SC or 16 mg/kg IV on Day 1.

Participants will receive Dexamethasone (d) therapy either orally (PO) or intravenously (IV) as follows:

* Cycles 1 and 2: 40 mg/dose on Days 1, 8, and 15; 20 mg/dose on Day 22
* Cycles 3 and 4: 40 mg/dose on Days 1, 8, and 15
* Cycles 5 through 8: 20 mg/dose on Days 1, 8, and 15.

Participants will receive Acetaminophen orally (PO) prior to Iber-KDd therapy as follows:

* Cycles 1 and 2: 650 mg/dose on Days 1, 8, 15, and 22
* Cycles 3 through 6: 650 mg/dose on Days 1 and 15
* Cycles 7 and 8: 650 mg/dose on Day 1.

Participants will receive Diphenhydramine either orally (PO) or intravenously (IV) prior to Iber-KDd therapy as follows:

* Cycles 1 and 2: 25 mg/dose on Days 1, 8, 15, and 22
* Cycles 3 through 6: 25 mg/dose on Days 1 and 15
* Cycles 7 and 8: 25 mg/dose on Day 1.

Participants will receive Montelukast orally (PO) prior to Iber-KDd as follows:

* Cycle 1 only: 10 mg/dose, Days 1, 8, 15, and 22, to be administered prior to the first 4 doses of Daratumumab (D).

Michelle D Armogan

Carl O Landgren, MD, PhD

Benjamin Diamond, MD

The investigators want to find out whether or not giving patients who have relapsed or refractory multiple myeloma (MM) the experimental medication combination iberdomide, carfilzomib, daratumumab, and dexamethasone (Iber-KDd) may produce better results than the current (standard of care) treatments. This study will examine the tolerability and efficacy of this combination therapy for all participants and the ability of this combination therapy to shrink or prevent MM from returning.

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

The rate of minimal residual disease negativity (MRD-negativity) will be reported as the number of participants achieving MRD-negativity after eight cycles of Iber-KDd combination therapy. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed.

The safety and tolerability of Iber-KDd combination therapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of combination therapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

Best response will be reported as the proportion of participants achieving their greatest response to Iber-KDd combination therapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iber-KDd combination therapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

Best response will be reported as the proportion of participants achieving their greatest response to Iberdomide monotherapy as follows: Partial response (PR) or better, very good partial response (VGPR) or better, complete response (CR), and stringent complete response (sCR). Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

Overall response rate (ORR) is defined as the number of participants achieving partial response (PR), very good partial response (VGFR)m complete response (CR) or stringent complete response (sCR) to Iberdomide monotherapy. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

Duration of Response (DOR) to Iber-KDd combination therapy will be assessed. Duration of response (DOR) is defined as time from response to progression of disease or death, whichever occurs first.

Overall survival (OS) is defined as the time from date of first dose of study treatment to death from any cause.

Progression-free survival (PFS) is defined as time from date of first dose of study treatment to time of progression or death, whichever occurs first.

Event-free survival (EFS) is defined as time from date of first dose of study treatment until 1) toxicity requiring removal from study, 2) progression, or 3) death, whichever occurs first.

The rate of sustained minimal residual disease negativity (MRD-negativity) at the completion combination Iber-KDd therapy and 12 cycles of iberdomide monotherapy will be assessed. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed. The number of participants will sustained Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

The rate of MRD-negativity as best response will be assessed among participants completing Iberdomide monotherapy. The number of participants with MRD-negativity at the 10\^-5 sensitivity will be reported. MRD-negativity is defined as less than one (\<1) residual cancer cell detected in 100,000 cells assessed. Response will be assessed using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma.

The safety and tolerability of Iber monotherapy will be assessed and reported as the number of participants experiencing treatment-related toxicity after start of monotherapy, including treatment-related adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

Bristol-Myers Squibb

Carl Ola Landgren, MD, PhD

Professor of Clinical

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Doxorubicin

Liposomal doxorubicin

Patients will receive motelukast 10 mg for 4 cycles of AC.

Patients will receive placebo tablets for 4 cycles of AC.

Placebo

Rehab H Werida, Ass. Prof.

Naglaa Fathy, Bachlor

Noha El Bassiouny, Lecturer

Naglaa Fathy, bachelor

Noha A. El bassiouny, Lecturer

This is a prospective, randomized (1:1) controlled trial that will be carried out on 50 patients who are candidate to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity after 4 cycles of AC. Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and group (B) for montelukast. Blood samples will be collected from the study subjects and analyzed for serum levels of the NF-KB and pro-BNP. Assessment of the biomarkers will be done at two time points: at baseline and after treatment with montelukast.

The primary objective of this study is to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients through assessing serum NT-proBNP and NF-KB. The secondary objective is to evaluate the safety and side effects of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients.

Methodology and study design:

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
2. About 50 patients who are candidate to the study will be recruited from Damanhour Cancer Institute.
3. All participants will provide an informed consent.
4. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
5. About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC. At each time point blood samples will be collected into plain test tubes and centrifuged at 4500×g for 10 min and serum will be frozen at - 80 ◦C until analysis of the biomarkers using ELISA kits.
6. Montelukast tablets will be provided on monthly intervals and the participants' adherence will be assessed through the medications refilling rate. Participants will also be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence and report any drug related adverse effects.

a prospective, randomized (1:1) controlled trial that will be carried out on 50 patients who are candidate to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity after 4 cycles of AC. Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and group (B) for montelukast

prospective, double blind randomized (1:1) controlled trial

Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients.

serum concentration of the pro-BNP (ng/dl)

Damanhour University

Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antirheumatic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Osimertinib

Antibodies

Methotrexate

Antibodies, Bispecific

Immunoglobulins

Lazertinib

Amivantamab-vmjw

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.

Dexamethasone will be administered orally.

Methotrexate will be administered subcutaneously.

Amivantamab will be administered intravenously.

Amivantamab

Lazertinib tablets will be administered orally.

Janssen Research & Development, LLC Clinical Trial

The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma	NCT04268498	Multiple Myelom...	Bortezomib Dexamethasone Lenalidomide Acetaminophen Diphenhydramine Montelukast Carfilzomib Daratumumab Autologous Stem...	18 Years - 75 Years	University of Miami
Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma	NCT05896228	Refractory Mult... Relapsed Multip...	Iberdomide Carfilzomib Daratumumab Dexamethasone Acetaminophen Diphenhydramine Montelukast	18 Years - 75 Years	University of Miami
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer	NCT05959889	Breast Cancer Doxorubicin Ind...	Placebo Montelukast	18 Years - 70 Years	Damanhour University
Premedication to Reduce Amivantamab Associated Infusion Related Reactions	NCT05663866	Carcinoma, Non-...	Dexamethasone Montelukast Methotrexate Amivantamab Lazertinib	18 Years -	Janssen Research & Development, LLC
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer	NCT05959889	Breast Cancer Doxorubicin Ind...	Placebo Montelukast	18 Years - 70 Years	Damanhour University
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma	NCT06356571	Plasma Cell Mye...	Isatuximab SC-O... Montelukast Dexamethasone Acetaminophen Diphenhydramine Methylprednisol... Carfilzomib	18 Years -	Sanofi
Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma	NCT05896228	Refractory Mult... Relapsed Multip...	Iberdomide Carfilzomib Daratumumab Dexamethasone Acetaminophen Diphenhydramine Montelukast	18 Years - 75 Years	University of Miami
A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma	NCT01998971	Multiple Myelom...	Daratumumab Velcade Pomalidomide Dexamethasone Melphalan Prednisone Thalidomide Diphenhydramine Acetaminophen Carfilzomib Lenalidomide Montelukast	18 Years -	Janssen Research & Development, LLC
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma	NCT04268498	Multiple Myelom...	Bortezomib Dexamethasone Lenalidomide Acetaminophen Diphenhydramine Montelukast Carfilzomib Daratumumab Autologous Stem...	18 Years - 75 Years	University of Miami

Spots Global Cancer Trial Database for montelukast

Every month we try and update this database with for montelukast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for montelukast

Every month we try and update this database with for montelukast cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for montelukast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.