Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Large B-Cell, Diffuse

Disease Progression

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Acute Graft Versus Host Disease

Experimental: ARM A:

Study participants who are not receiving a moderate or strong CYP3A4 inhibitor.

Dose Escalation Phase:

* Cohort 1: Participants with acute leukemia
* Cohort 2: Participants with diffuse large B-cell lymphoma
* Cohort 3: Participants with multiple myeloma
* Cohort 4: Participants with chronic lymphocytic leukemia/ small lymphocytic lymphoma

Participants will receive escalating dose BMF-219 orally once per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose).

Dose Expansion Phase:

Cohorts 1, 2, 3, and 4 will receive BMF-219 at the OBD/ RP2D to further assess the safety/ efficacy of the investigational drug.

Experimental: ARM B:

Study participants who are receiving a moderate or strong CYP3A4 inhibitor.

Dose Escalation Phase:

• Cohort 1: Participants with acute leukemia will receive escalating dose BMF-219 orally to identify the OBD/ RP2D (Optimal Biologic Dose/Recommended Ph2 Dose).

Dose Expansion Phase:

Cohort 1 will receive BMF-219 at the OBD/ RP2D to further assess the safety and efficacy of the investigational drug.

BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used.

BMF-219

Mona Vimal

Clarissa Mandap

Alex Cacovean, MD

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) with mixed lineage leukemia 1-rearranged (KMT2A/ MLL1r), nucleophosmin 1 (NPM1), diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic lymphoma (CLL)/ small lymphocytic lymphoma (SLL).

The first-in-human (FIH) study is a dose-escalation/dose-expansion study of BMF-219. During the dose-escalation phase of the study, the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 will be determined. Subjects in Cohort 1 (acute leukemia) are assigned to one of two parallel arms; ARM A (subjects not receiving CYP3A4 inhibitors) and ARM B (subjects receiving CYP3A4 inhibitors); Subjects in Cohort 2 (DLBCL), Cohort 3 (multiple myeloma), and Cohort 4 (chronic lymphocytic leukemia/ small lymphocytic lymphoma) are assigned to a single arm (ARM A).The dose-expansion phase will obtain further safety, as well as efficacy data for BMF-219 when dosed at the OBD and RP2D.

Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL

A Phase 1 First-in-human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Covalent Menin Inhibitor, in Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), and Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)

Determine Optimal Biologic Dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy in subjects with refractory or relapsed (R/ R) acute leukemia (Cohort 1), diffuse large B-cell lymphoma (Cohort 2), multiple myeloma (Cohort 3), and chronic lymphocytic leukemia/ small lymphocytic lymphoma (Cohort 4).

Evaluate the Safety of BMF-219 as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Biomea Fusion Inc.

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Dexamethasone acetate

Panobinostat

Ixazomib

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Histone Deacetylase Inhibitors

Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 4mg on day 1, 8, 15, 28

MLN9708

Jason Valent, MD

Ehsan Malek, MD

This study will look at the safety and tolerability of the new drug MLN9708 in combination with the existing drugs panobinostat and dexamethasone among patients with relapsed or refractory multiple myeloma. This study will also look at the response and clinical benefit of the treatment and the progression-free survival and overall survival of study participants.

The primary objective of this study is to define the tolerability and safety of MLN9708 (ixazomib) administered on a day 1,8,15 every 28 day schedule up to 4mg in combination with fixed doses of panobinostat and dexamethasone in patients with relapsed or refractory myeloma.

The secondary objectives of this study are to assess response and clinical benefit response rates according to international uniform response criteria and adapted EBMT criteria, respectively. And to assess progression-free survival (PFS) and overall survival (OS).

MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma

A Phase I/II Study of MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Number of Participants with Dose Limiting Toxicity of MLN9708 (lxazomib) according to CTCAE version 4.03

Response to intervention as measured by international uniform response criteria and clinical benefit response according to modified EBMT response criteria, comparing myeloma panels obtained at the beginning of each cycle that include SPEP, 24 h UPEP, serum and urine IFEs, and serum free light chains to results at screening. In addition a baseline bone marrow exam and skeletal survey will be obtained and repeated as clinically indicated and for assessment of complete remission (bone marrow)

Progression-free survival will be the number of days from study entry to progression or death of any cause, whichever comes first.

Progression-free survival is survival with absence of progressive disease, defined by

* An increase of 25% from lowest response value in any one or more of the following:

  * Serum M-component (absolute increase must be \>0.5 g/100 ml) \*
  * Urine M-component (absolute increase must be \>200mg per 24 h)
  * Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100 mg/l)
  * Bone marrow plasma cell percentage (absolute % must be \>10%)
* And / or:

  * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
  * Development of hypercalcemia (corrected serum calcium \>11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder

Overall survival for all will be the number of months from study entry to death from any cause.

Jason Valent

Principal Investigator

Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28

DL1 - 3mg Lxazomib

DL2 - 4mg Lxazomib

Phase I

Phase I/II

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dose Levels 1

All participants who received treatment in the phase I portion of the study

Number of Participants With Dose Limiting Toxicity According to CTCAE Version 4.03

Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708)

Progression-free Survival

Overall Survival

Weeks 1-4

Phase II Portion of Study at DL2

Bone Marrow Neoplasms

Bortezomib

Belinostat

PXD101

This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.

A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Valerio Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL	NCT05153330	Acute Myeloid L... Acute Lymphobla... Acute Mixed-Phe... Cancer Refractory Progression Diffuse Large B... Multiple Myelom... Lymphoma Lymphoma, Non-H... Myeloma, Plasma... Myelomatosis Plasma Cell Mye... Chronic Lymphoc... Small Lymphocyt...	BMF-219	18 Years -	Biomea Fusion Inc.
MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma	NCT02057640	Multiple Myelom... Kahler Disease Plasma-Cell Mye... Myelomatosis	Panobinostat Dexamethasone MLN9708	18 Years -	Case Comprehensive Cancer Center
MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma	NCT02057640	Multiple Myelom... Kahler Disease Plasma-Cell Mye... Myelomatosis	Panobinostat Dexamethasone MLN9708	18 Years -	Case Comprehensive Cancer Center
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma	NCT00431340	Multiple Myelom...	PXD101	18 Years -	Valerio Therapeutics
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma	NCT00431340	Multiple Myelom...	PXD101	18 Years -	Valerio Therapeutics
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL	NCT05153330	Acute Myeloid L... Acute Lymphobla... Acute Mixed-Phe... Cancer Refractory Progression Diffuse Large B... Multiple Myelom... Lymphoma Lymphoma, Non-H... Myeloma, Plasma... Myelomatosis Plasma Cell Mye... Chronic Lymphoc... Small Lymphocyt...	BMF-219	18 Years -	Biomea Fusion Inc.

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