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

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Anti-Infective Agents

Dexamethasone

Aspirin

Lenalidomide

Dexamethasone acetate

BB 1101

Amrubicin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

* Aspirin: 81 or 325 mg daily oral
* Pegfilgrastim subcutaneous on Day 2

Pegfilgrastim

Michaela Liedtke

To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.

PRIMARY OBJECTIVES

* Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I
* Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)

SECONDARY OBJECTIVES

* Determine the overall response rate (CR, VGPR and PR)
* Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

A Phase 1 Study of Amrubicin in Combination With Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

Modified International Myeloma Working Group Uniform Response Criteria:

Complete (CR)=

* Negative for monoclonal protein (MP) in urine (U) and serum (S) +
* No tissue plasmacytomas (PC) +
* \<5% plasma cells (PCs) in marrow (M)

Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M

Near CR (nCR)= CR, except MP persists in U and S

Partial (PR)= S MP ≤50%, + U MP ≤90% or \<200 mg/24 hours (hr)

Very Good PR (VGPR)= in S MP ≤90%, + U MP \<100 mg/24 hr

Minimal (MR)=

* S MP ≤51-75%, +
* If light chain is excreted, reduced 50-89%/24 hr that is also \>200 mg/24 hr, +
* No increase in lytic bone lesions

Progressive disease (PD)= any of:

* S MP ≥125% and/or ≥+0.5 g/dL,
* U MP ≥125% and/or ≥+200 mg/24 hr
* New or increased bone lesions/PC
* S calcium \>11.5 mg/dL (attributed to increased PCs)

PD after CR/sCR=

* Reappearance of S or U MP
* ≥5% clonal PCs in M
* New PC, lytic bone lesions, hypercalcemia

Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD

Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:

* Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,
* Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline
* New or increased bone lesions or plasmacytomas
* Serum calcium \> 11.5 mg/dL (attributed to increased plasma cells)

Celgene Corporation

Assistant Professor Medicine/Hematology

Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

* Aspirin: 81 or 325 mg daily oral
* Pegfilgrastim subcutaneous on Day 2

Amrubicin + Lenalidomide + Dexamethasone

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Michaela Liedtke, MD

Complete Response (CR) rate

Very Good Partial Response (VGPR) Rate

Total CR + VGPR

Partial Response (PR) Rate

Overall Response Rate (ORR = CR + VGPR + PR)

Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria

Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.

Concurrent therapeutic medications:

* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14
* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)

Other drugs:

* Aspirin: 81 or 325 mg daily oral
* Pegfilgrastim subcutaneous on Day 2

Amrubicin: 40, 60, or 80 mg/m2 intravenous (IV)

Lenalidomide: 15 mg daily by mouth

Dexamethasone: 40 mg weekly by mouth

Aspirin: 81 or 325 mg daily by mouth

Pegfilgrastim: 6 mg subcutaneous on Day 2

Duration of Response (DOR)

Progression-free Survival (PFS)

Time-to-next Treatment

Overall Study

Spots Global Cancer Trial Database for Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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