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

Disease Progression

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

Revlimid dosing will be in the morning at the same time each day

10 mg/day in the morning same time each day

Revlimid

Bart Barlogie, MD, PhD

The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).

Determine the associated toxicities in qualitative and quantitative terms using NCI CTCAE(NCI common terminology for adverse events)

UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma

Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3) Trials 2003-33 and 2006-66

Progression was defined as any one or more of the following:

* Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or
* Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or
* If patient had serum M protein \< 1 g/dL, urine M protein \< 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or
* Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or
* New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or
* Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma.

University of Arkansas

Revlimid: 10 mg/day in the morning same time each day

Observation

Total

Age, Categorical

Sex: Female, Male

White

Other

Race/Ethnicity, Customized

Bart Barlogie

Progression Free Survival (PFS)

Overall Study

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Dexamethasone

Pomalidomide

Dexamethasone acetate

Ixazomib

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Protasome/IMiD combination of Ixazomib 4mg days 1, 8, and 15, Pomalidomide 4mg days 1-21 amd Dexamethasone 20 mg days 1, 8, 15 and 22 of a 28 day cycle

4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle

4.0 mg will be given on days 1-21 of a 28 day cycle

20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle

Faith Davies, MD

The purpose of this study is to determine the efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma

This single arm, Phase II study will examine the efficacy and safety of the novel Proteasome/IMiD combination of Ixazomib 4mg days 1, 8, 15, Pomalidomide 4 mg days 1-21, Dexamethasone 20 mg days 1, 8, 15, and 22 of a 28 day cycle, in relapse patients. The long term aim being to develop a backbone regimen to which future novel targeted treatments may be added as part of a personalized medicine approach.

UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination

A Phase II Trial of a Novel Proteasome/IMiD Combination, Ixazomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma Patients

Response rate will be assessed at baseline, with each scheduled study visit , including the exit visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma	NCT01621672	Multiple Myelom...	Revlimid	18 Years -	University of Arkansas
UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination	NCT02578121	Multiple Myelom...	Ixazomib Pomalidomide Dexamethasone	18 Years -	University of Arkansas

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