Neoplasms

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All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Hematologic Diseases

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

IPI-504

Sundar Jagannath, MD

David S. Siegel, MD; Ph.D

Ivan Borrello, MD

Paul Richardson, MD

This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in patients with relapsed and/or relapsed, refractory multiple myeloma. This study will examine how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body. The study will also evaluate potential anti-tumor activity of IPI-504.

IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in regulating protein homeostasis. Hsp90 regulates the stability of key proteins (called "client proteins") and keeps them in the appropriate three dimensional shape so they can perform their cellular functions. In addition, many of the proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. Thus Hsp90, a single molecular target that is a central integrator of multiple pathways important to cancer, is an ideal novel target for oncologic therapy. Selective inhibition of Hsp90 will affect multiple downstream mechanisms to disrupt tumor growth and selectively kill cancer cells. The anti-neoplastic effects of Hsp90 inhibition have been demonstrated both in vitro and in vivo for a variety of different hematologic and solid tumors including multiple myeloma.

Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma

A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma

Infinity Pharmaceuticals, Inc.

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Thalidomide

Lenalidomide

Pomalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide maintenance given until disease progression. Long term follow-up 5 years post last patient randomized.

Observation until disease progression. Long term follow-up 5 years post last patient randomized.

Treatment with lenalidomide capsules 10 mg, 5mg daily or 5mg every other day given on days 1-21 of each 28 day cycle.

Yasir Nagarwala, MD

The purpose of this study is to see how long lenalidomide therapy can maintain or improve the disease response obtained after induction therapy that does not include lenalidomide, pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate the activity of lenalidomide. Patients will receive lenalidomide or be under observation. All patients will attend regular clinic visits to evaluate their disease and health. Patients will have the option to participate in additional biomarker correlative studies in addition to their participation in the main study.

Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma

Phase 3b, Randomized Trial of Continuous Revlimid® (Lenalidomide) Therapy Versus Observation Following Induction Therapy That Does Not Include Revlimid, Pomalyst® or Thalomid® in Newly Diagnosed Multiple Myeloma

Time from randomization to the documentation of disease progression

Response is defined according to the international Myeloma Working Group (IMWG) Response Criteria (Durie, 2006). Overall response rate over time (complete response \[CR\], very good partial response \[VGPR\], partial response \[PR\], stable disease \[SD\]

The time to progression is defined from randomization to progression as defined by the international Myeloma Working Group (IMWG) Criteria (Durie, 2006)

Time from randomization to the date of death due to any cause

Number of patients with adverse events and relationship of adverse events, laboratory abnormalities, and hospitalizations to study drug / study observation

Celgene

Symptoms and General Pathology

Neoplasm, Residual

Antibodies

Immunomodulating Agents

Immunoglobulins

Newly diagnosed MM patients who have minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT)

Single dose infusion of CIML NK Cells plus KP1237 followed by low dose IL-2

CIML NK Cells plus KP1237 and low dose IL-2

Chief Medical Officer

Giada Bianchi, MD

This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of cytokine induced memory-like (CIML) NK cells plus KP1237 and low dose IL-2 in newly diagnosed MM patients who have minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT).

Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients

A Phase 1 Study of Autologous Memory-like Natural Killer (NK) Cell Immunotherapy With BHV-1100 (Formerly KP1237) and IVIG Followed by Low Dose IL-2 as Early Post-Autologous Transplant Consolidation in Minimal Residual Disease Positive, Multiple Myeloma (MM) Patients in First or Second Remission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma	NCT00113204	Multiple Myelom...	IPI-504	18 Years -	Infinity Pharmaceuticals, Inc.
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma	NCT00113204	Multiple Myelom...	IPI-504	18 Years -	Infinity Pharmaceuticals, Inc.
Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma	NCT02155634	Multiple Myelom... Neoplasms Plasma Cells Paraproteinemia... Blood Protein D... Hematologic Dis... Therapeutic Use...	Lenalidomide	18 Years -	Celgene
Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients	NCT04634435	Multiple Myelom...	CIML NK Cells p...	18 Years - 75 Years	Biohaven Pharmaceuticals, Inc.
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma	NCT00113204	Multiple Myelom...	IPI-504	18 Years -	Infinity Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for plasma cells

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