Neoplasms

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Blood and Lymph Conditions

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All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Recurrence

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Disease Attributes

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Dexamethasone acetate

Ixazomib

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression

Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress

Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress

Iberdomide

Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22

Dexamethasone Oral

Cyrille Touzeau

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .

The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

Number of adverse events defined by Common Terminology Criteria for Adverse Events (v5)

Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG

is defined as the time in months from inclusion to the date of death due to any cause. Subject alive will be censored at the last known alive date.

is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria

is defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause

is defined as the time from treatment initiation to the last dose of therapy

prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14),

Nantes University Hospital

Lenalidomide

Bortezomib

Daratumumab

BB 1101

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm.

Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle.

Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle.

Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after.

Daratumumab Injection

The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.

Lenalidomide will be given orally on days 1-21 of a 28 days cycle. The starting dose of lenalidomide will be based on the patient creatinine clearance per the package insert.

Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide.

Patients with a creatinine clearance \< 30 ml/min are not eligible but patients who experience a deterioration in the renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable, that study therapy is in the best interest of the patient and after discussion with the study principal investigator / sponsor.

Lenalidomide Pill

Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.

Bortezomib Injection

Rachid C Baz, MD

This is a Phase II study of daratumumab based therapies for older adults with multiple myeloma.

In this response adapted approach, older adults with newly diagnosed symptomatic multiple myeloma will receive daratumumab and dexamethasone for 2 months. Patients who achieve a partial response or better will continue on daratumumab. Patients who achieve less than a partial response will have lenalidomide or bortezomib added to their therapy. Patients who experience progressive disease on daratumumab after the initial 2 months of monotherapy or on the combination of daratumumab and either lenalidomide or bortezomib will come off study

Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma

Phase II Study of Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma

The number of participants who continue on Daratumumab and Dexamethasone after 2 cycles

The number of patients who are without minimal residual disease (MRD) using Next Generation Sequencing (NGS) will be estimated and the 95% confidence interval will be computed by the Clopper-Pearson method.

Overall Response Rate (partial response or better) of the response adapted strategy using the uniform response criteria of the International Myeloma Working Group (IMWG).

Progression Free Survival (PFS) from start of treatment to death of any cause, disease progression or relapse of the date of last follow-up, whichever comes first. he PFS will be estimated by the Kaplan-Meier method and 95% confidence interval (CI) will be computed by complementary log-log transformation. The 1 and 2 year PFS and 95% Confidence Intervals will be reported.

Overall Survival (OS) from start of treatment to death of any cause or the date of last follow-up, whichever comes first. OS will be estimated by the Kaplan-Meier method and 95% confidence interval will be computed by complementary log-log transformation. The 2 year OS and 95% CI will be reported.

Janssen Scientific Affairs, LLC

H. Lee Moffitt Cancer Center and Research Institute

Pomalidomide

Elotuzumab

Selinexor will be given as an oral dose:

40 mg (2 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.

* Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
* Patients ≤75 years:

  o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
* Patients \> 75 years:

  * Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.

Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.

* Pomalidomide will be given as an oral 4 mg dose once a day (QD) on Days 1 to 21 of each 28-day cycle.
* Patients ≤75 years:

  * Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing
  * Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
* Patients \>75 years:

  * Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing
  * Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.

Selinexor will be given as an oral dose 40 mg (2 20 mg tablets) QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Selinexor

Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.

Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.

Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Preferred dosing of dexamethasone is 40 mg QW for patients who are ≤75 years of age (20 mg QW for \>75-year-old patients at the Investigator's discretion) before QW dosing of selinexor, however, it may be divided over 2 days at the Investigator's discretion.

European Myeloma Network (EMN)

Muhammad Husnain

Haifaa Abdulhaq

Ashraf Aziz

Lasika Seneviratne

James Berenson

Merrill Shum

Steven Schuster

Faithlore Gardner

Gustavo Fonseca

Viralkumar Bhanderi

Shachar Peles

Fukumoto

Jon Fukumoto

Donald Wender

Michael Castine

Ralph Boccia

Daniel Lebovic

Irfan Vaziri

Subramanyeswara Arekapudi

Tulin Budak-Alpdogan

Darla Liles

Franklin Chen

Terrence Cescon

Hamza Hashni

Tondre Buck

Jonathan Lu

Manier

Moreau

moreau

Mohty

Morel

Frenzel

Leleu

Perrot

Weisel

Scheid

Khandanpour

Einsele

Evangelos Terpos

Delimpasi

Pouli

Symeonidis

Katodrytou

Offidani

Alessandro

Cavo

Angelo Belotti, MD

Belotti

Derudas

Alberto Bosi, MD

Aquino

Cerchione

Musolino

Andrea Novali

De Fabritiis

Liberati

Alessandra Larocca, MD

Francesca Patriarca, MD-PhD

van der Klift

Wester

Rosiñol

Sureda

Martínez-López

De Arriba de la Fuerte

Rodriguez

Mateos

Ocio

Gonzalez Pérez

de la Rubia

This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

from date of randomization until the date of first confirmed progressive disease (PD), per IMWG response criteria, or death due to any cause, whichever occurs first.

defined as any response ≥PR (i.e., PR \[partial response\], VGPR \[very good partial response\], CR (\[complete response\], or sCR \[stringent complete response\])

Duration of response (PR or better), duration of CR, duration of sCR, and duration of minimal residual disease (MRD) -negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, whichever occurs first.

Time to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR)

Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.

The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.

The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"

Safety and tolerability of study treatment will be evaluated based on occurrence, nature and severity of adverse events as categorized by the Common Terminology Criteria of Adverse Events (CTCAE) v5.0

Karyopharm Therapeutics Inc

Stichting European Myeloma Network

Alternating cycles of:

Selinexor oral 40mg once weekly Lenalidomide oral 25mg d 1-21 Dexamethasone 20mg d 1+2, 8+9 and 15+16 i 28 days cycles and Selinexor oral 80mg once weekly Bortezomib sc 1.3mg/sqm once weekly Dexamethasone 20mg d 1+2, 8+9 and 15+16 in 28 days cycles for up to 16 cycles (8 of each, alternating) followed by continuos selinexor 40mg(once weekly)-lenalidomide-dexamethasone

for up to 16 cycles followed by continuos lenalidomide-dexamethasone

Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

Selinexor 20 MG Oral Tablet

Lenalidomide capsule

Ida B Kristensen, MB

Hanne Norseth, MD

An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group

An unrandomized phase 2 study evaluating selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up with in the Nordic Multiple Myeloma Study Group.

The study will include 50 patients, recruited within the NMSG collaborating countries. After induction patient will be treated with continued lenalidomide-dexamethasone according to SWOG, with continuous 40mg selinexor weekly in the selinexor arm (experimental arm B).

Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients

Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients (SABLe): An Investigator Sponsored Trial

ORR at end of induction, with response defined according to IMWG response criteria

MRD negativity by NGS at end of induction

Time to at least PR from start of treatment

Comparison of toxicity rates according to NCI-CTCAE v4.03

Time to at least VGPR from start of treatment

Odense Patient Data Explorative Network

Ida Bruun Kristensen

Lymphoma

Lymphoma, Non-Hodgkin

Lymphatic Diseases

Lymphosarcoma

Participants with r/r NHL or r/r MM will be treated with oral CFT7455 as a single agent administered according to different dosing schedules

Participants with r/r MM will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

Participants with r/r MM will be treated with oral CFT7455 in combination with a fixed dose of oral dexamethasone in each cohort

Participants with r/r NHL will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules in each cohort until determination of MTD/RP2D

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."	NCT04998786	Multiple Myelom...	Ixazomib Iberdomide Dexamethasone O...	70 Years -	Nantes University Hospital
Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma	NCT04151667	Multiple Myelom...	Daratumumab Inj... Dexamethasone O... Lenalidomide Pi... Bortezomib Inje...	65 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."	NCT04998786	Multiple Myelom...	Ixazomib Iberdomide Dexamethasone O...	70 Years -	Nantes University Hospital
A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma	NCT05028348	Multiple Myelom...	Selinexor Elotuzumab Pomalidomide Dexamethasone O...	18 Years -	Stichting European Myeloma Network
Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients	NCT04717700	Multiple Myelom...	Selinexor 20 MG... Bortezomib Inje... Lenalidomide ca... Dexamethasone O...	18 Years -	Odense University Hospital
Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma	NCT04756726	Multiple Myelom... Lymphoma, Non-H...	CFT7455 Dexamethasone O...	18 Years -	C4 Therapeutics, Inc.
Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma	NCT04151667	Multiple Myelom...	Daratumumab Inj... Dexamethasone O... Lenalidomide Pi... Bortezomib Inje...	65 Years -	H. Lee Moffitt Cancer Center and Research Institute
Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma	NCT04151667	Multiple Myelom...	Daratumumab Inj... Dexamethasone O... Lenalidomide Pi... Bortezomib Inje...	65 Years -	H. Lee Moffitt Cancer Center and Research Institute

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