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

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Iberdomide

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of email MUST contain NCT # and Site #.

Robert Rifkin, Site 0202

Sikander Ailawadhi, Site 0007

Site 0308

Site 0192

Chakra Chaulagain, Site 0003

Charles Bodine, Site 0019

Sagar Lonial, Site 0018

Amany Keruakous, Site 0021

Benjamin Derman, Site 0237

Al-Ola Abdallah, Site 0015

Jose Mendoza, Site 0205

Site 0279

Matthew Pianko, Site 0001

Philip Kuriakose, Site 0257

Andrew Sochacki, Site 0296

Site 0303

John Hrom, Site 0207

Suman Kambhampati, Site 0017

Mohamad Cherry, Site 0191

Gareth Morgan, Site 0288

Gareth Morgan, Site 0180

Divaya Bhutani, Site 0020

James D'Olimpio, Site 0274

Raymond Thertulien, Site 0005

Cristina Gasparetto, Site 0281

Raymond Thertulien, Site 0286

Kruti Patel, Site 0238

Sandra Mazzoni, Site 0299

Sandra Mazzoni, Site 0002

Sandra Mazzoni, Site 0301

Ahmad Zarzour, Site 0013

Sandra Mazzoni, Site 0300

Christopher Yasenchak, Site 0203

Adam Binder, Site 0012

Kathleen Dorritie, Site 0253

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Houston Holmes, Site 0193

Larry Anderson, Site 0009

Robert Orlowski, Site 0006

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Akash Kalro, Site 0088

Olga Motorna, Site 0220

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Petra Pichler, Site 0034

Maria-Theresa Krauth, Site 0056

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Irwindeep Sandhu, Site 0270

Arleigh McCurdy, Site 0208

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Marc Lalancette, Site 0210

Raimundo Gazitua, Site 0186

Eduardo Yanez Ruiz, Site 0258

Javiera Donoso, Site 0099

Yongsheng Han, Site 0196

Site 0100

Wenrong Huang, Site 0229

Site 0242

Xin Du, Site 0261

Site 0079

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Baijun Fang, Site 0246

yanjuan He, Site 0262

Site 0282

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Fei Li, Site 0263

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Yafei Wang, Site 0249

Haitao Meng, Site 0243

Jin Lu, Site 0216

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Site 0231

Bristol-Myers Squibb

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Idecabtagene vicleucel

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

* bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 800 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy with a planned starting dose of 450 x 10\^6 CAR+ T cells.
* Lenalidomide maintenance therapy is recommended for all patients and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later

bb2121

This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.

A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)

A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4)

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

DLTs will be assessed during the DLT interval (ie, within 21 days immediately after bb2121 infusion). DLTs are defined as any bb2121 related Grade 3 to 5 toxicity.

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

Is defined as proportion of subjects who achieved CR or better according to IMWG Uniform Response Criteria for Multiple Myeloma for multiple myeloma will be determined by an Investigator assessment.

Is defined as proportion of subjects who achieved PR or better according to IMWG Uniform Response Criteria for Multiple Myeloma as determined by an Investigator assessment

Is defined as time from first documentation of response (PR or better) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first, for responders.

Is defined as time from bb2121 infusion date to first documentation of CR for responders (Complete Response (CR) or better).

Is defined as time to start lenalidomide maintenance therapy post-bb2121 infusion

Number of subjects starting the maintenance or on maintenance between D90 and D110

Is defined as time from bb2121 infusion date to first documentation of PD, or death due to any cause, whichever occurs first.

Is defined as time from bb2121 infusion date to time of death due to any cause

Area under the curve of the transgene level

Celgene

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Bortezomib

Daratumumab

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Carfilzomib, Daratumumab, Lenalidomide, Dexamethasone

Carfilzomib on Days 1, 8, 15, of cycle numbers 1-9 and Days 1 and 15 only of cycle numbers 10-18, at a dose of 20 mg/m2 on day 1 of cycle 1; at dose of 56 mg/m2 on all subsequent once weekly dosing days. The quadruple regimen treatment will be administered for 18 cycles.

Carfilzomib

Daratumumab : 16 mg/Kg weekly for 8 weeks, then every 2 weeks for 16 weeks, and then every 4 weeks thereafter. The quadruple regimen treatment will be administered for 18 cycles.

Lenalidomide (25 mg), administered on days 1-21 of 28-day cycle.In frail patients, Lenalidomide dose will be reduced according to 15 mg . The quadruple regimen treatment will be administered for 18 cycles.

Patients will be treated with IV or oral dexamethasone (20 mg for fit and INT-FIT, 10 mg for frail), administered on Days 1-2, 8-9, 15-16, and 22-23 of each 28-day cycle for cycles 1-2 followed by weekly 20 mg dexamethasone on subsequent cycles; In frail patients, dexamethasone will be reduced to 10 mg . The quadruple regimen treatment will be administered for 18 cycles.

Yael Cohen, MD

Patients with newly diagnosed multiple myeloma (NDMM) who failed to achieve at least a minimal response (MR) after 2 cycles or a partial response (PR), after 4 cycles of a bortezomib-containing therapy, or progress on therapy during first 4 cycles (response defined by international Myeloma Working Group \[IMWG\] criteria), will be treated with a quadruple regimen comprised of: Daratumumab 16 mg/Kg weekly during cycles 1-2, q14 days during cycles 3-6, thereafter monthly (1st dose cycle 1 may be split over 2 days); Once-weekly intravenous (IV) administration of Carfilzomib on days 1, 8, 15, of cycle numbers 1-9 and Days 1 and 15 only of cycle numbers 10-18, at a dose of 20 mg/m2 on day 1 of cycle 1; at dose of 56 mg/m2 on all subsequent once weekly dosing days, alongside concomitant treatment with twice-weekly IV or oral dexamethasone 20mg administered on Days 1-2, 8-9, 15-16, and 22-23 of a 28-day cycle, for cycles 1-2 followed by weekly 20 mg dexamethasone on subsequent cycles; and oral Lenalidomide 25 mg, administered on days 1-21 of a 28-day cycle. On treatment days that require both Carfilzomib and Daratumumab infusions, Carfilzomib will be administrated prior to Daratumumab administration. All patients will undergo frailty assessment based on IMWG recommendations, and will be classified as fit, intermediate-fit and frail. Frail patients will receive Lenalidomide dose adjustment to 15 mg (throughout the study, from cycle 1 and on), and dexamethasone at 10 mg x 2/week cycles 1-2 followed by 10 mg/week for subsequent cycles. The quadruple regimen will be administered for 18 cycles, followed by long-term follow-up in which patients will receive standard of care treatment with Lenalidomide/dexamethasone (Rd) treatment, unless disease progression, the physician decides otherwise, the patient suffers from unacceptable toxicity, withdraws consent, or dies (whichever occurs first).

Patients with newly diagnosed multiple myeloma (NDMM) who failed to achieve at least a minimal response (MR) after 2 cycles or a partial response (PR), after 4 cycles of a bortezomib-containing therapy, or progress on therapy during first 4 cycles (response defined by international Myeloma Working Group \[IMWG\] criteria), will be treated with a quadruple regimen comprised of: Daratumumab 16 mg/Kg weekly during cycles 1-2, q14 days during cycles 3-6, thereafter monthly (1st dose cycle 1 may be split over 2 days); Once-weekly intravenous (IV) administration of Carfilzomib on days 1, 8, 15, of cycle numbers 1-9 and Days 1 and 15 only of cycle numbers 10-18, at a dose of 20 mg/m2 on day 1 of cycle 1; at dose of 56 mg/m2 on all subsequent once weekly dosing days, alongside concomitant treatment with twice-weekly IV or oral dexamethasone 20mg administered on Days 1-2, 8-9, 15-16, and 22-23 of a 28-day cycle, for cycles 1-2 followed by weekly 20 mg dexamethasone on subsequent cycles; and oral Lenalidomide 25 mg, administered on days 1-21 of a 28-day cycle. On treatment days that require both Carfilzomib and Daratumumab infusions, Carfilzomib will be administrated prior to Daratumumab administration. All patients will undergo frailty assessment based on IMWG recommendations, and will be classified as fit, intermediate-fit and frail. Frail patients will receive Lenalidomide dose adjustment to 15 mg (throughout the study, from cycle 1 and on), and dexamethasone at 10 mg x 2/week cycles 1-2 followed by 10 mg/week for subsequent cycles. The quadruple regimen will be administered for 18 cycles, followed by long-term follow-up in which patients will receive standard of care treatment with Lenalidomide/dexamethasone (Rd) treatment, unless disease progression, the physician decides otherwise, the patient suffers from unacceptable toxicity, withdraws consent, or dies (whichever occurs first). All patients will be required to receive either thromboprophylaxis or anticoagulation therapy in parallel. Patients will receive prophylaxis to herpes zoster and pneumocystis infection according to institutional guidelines, as well as proton pump inhibitors on dexamethasone treatment days only, according to institutional guidelines.

Patients will be assessed for response, to be determined by multiple myeloma (MM) biomarker profiling, on day 1 of cycle 2 and then every 56 ±4 days thereafter, irrespective of treatment delays or the timing of treatment cycles. Disease status will be followed until confirmed progressive disease (PD).

Long-term follow-up for disease status (only in cases where patients discontinued treatment prior to PD or patients completing all 18 cycles without signs of PD) and for survival (after reaching PD) will continue after treatment discontinuation until the patient has withdrawn consent for further participation, is lost to follow-up, has died, or the sponsor makes a decision to terminate the study. For patients who discontinued treatment before completing 18 cycles , without PD occurred, disease response assessments shall be performed every 56 days (±4 days), according to the original scheduled days of assessment, until disease progression. Patients completing all 18 cycles without signs of PD will be followed-up for disease response every 84±7 days. Follow-up for survival will be performed approximately every 3 months, or as needed, for all surviving patients until study closure. For any patient who is lost to follow-up, the study site will attempt to ascertain survival information via public database search.

The control group in this study (Historical Control) will consist of 144 consecutive patients from a subset of participating centers and will include transplant ineligible NDMM diagnosed between 2011 to 2017 with failure to respond to a bortezomib based induction (as defined in the prospective trial). Control group patients must meet the protocol inclusion and exclusion criteria.

Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients

Safety, Tolerability, and Efficacy of Once Weekly Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone, in Transplant-ineligible Multiple Myeloma Patients Non-responsive to a Bortezomib Based Induction

mutational transcriptional and post translational changes associated with drug sensitivity and resistance, clonal evolution

Determined by adverse events, vital signs and clinical laboratory parameters in relation to study intervention.

The fraction of patients who experience a partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per IMWG 2016 criteria.

Time of first evidence of PR or better to confirmation of PD or death due to any cause

From initiation of treatment to documented PD

Defined as ORR or minimal response (MR) or stable disease (SD) lasting at least 8 weeks.

The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-MY20 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-MY20 include 20 questions (items). Score scale is starting from minimum of 1 and up to a maximum of 4. Higher values represent a worse outcome.It is the complementary module of the QLQ-C30 which is specific for Multiple Myeloma patients.

The European Organization for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire Module QLQ-C30 will be used to evaluate Global Health Status/QoL. Questionnaire Module QLQ-C30 include 30 questions score scale is starting from minimum of 1 and up to a maximum of 7. In most items (1-28) Higher values represent a worse outcome.The exceptions are the items contributing to the global health status / QoL - 2 items (29-30) In which Higher values represent a better outcome .

It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.

Frailty assessment, for this study will be based only on 4 components : age, the Charlson Comorbidity Scoring System, the Katz Index of Independence in Activities of Daily Living and the Lawton Instrumental Activities of Daily Living Scale.

All above 4 components are summed up and combined into one MM Frailty score - The score system (range 0-5, higher values represent a worse outcome), identifies 3 groups of patients:

fit (score=0) intermediate-fitness (score=1) frail (score≥2)

Tel-Aviv Sourasky Medical Center

Selinexor 60 mg/day, orally on d1,8,15,22

Selinexor

Bortezomib 1.3mg/m2 intravenously on d1,8,15,22

Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma	NCT05827016	Multiple Myelom...	Iberdomide Lenalidomide	18 Years -	Bristol-Myers Squibb
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)	NCT04196491	Multiple Myelom...	bb2121 Fludarabine Cyclophosphamid... Lenalidomide	18 Years -	Celgene
Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients	NCT04065789	Myeloma Multipl... Myeloma, Plasma... Myeloma-Multipl... Plasma Cell Mye...	Carfilzomib Daratumumab Lenalidomide Dexamethasone	18 Years -	Tel-Aviv Sourasky Medical Center
Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients	NCT04065789	Myeloma Multipl... Myeloma, Plasma... Myeloma-Multipl... Plasma Cell Mye...	Carfilzomib Daratumumab Lenalidomide Dexamethasone	18 Years -	Tel-Aviv Sourasky Medical Center
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease	NCT05900882	Multiple Myelom...	Selinexor Bortezomib Lenalidomide Dexamethasone	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University
Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma	NCT02046070	Multiple Myelom...	Cyclophosphamid... Ixazomib Dexamethasone	18 Years -	Takeda
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma	NCT05827016	Multiple Myelom...	Iberdomide Lenalidomide	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for ndmm

Every month we try and update this database with for ndmm 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 ndmm

Every month we try and update this database with for ndmm 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 ndmm 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.