Trial Outcomes & Findings for Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma (NCT NCT00538824)

Last Updated: 2018-06-06

Results Overview

The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	DexTR (All Patients) All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
Overall Study STARTED	5
Overall Study Progression of Disease	2
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DexTR (All Patients) n=5 Participants All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
serum creatinine at baseline (in mg/dL)	3.8 mg/dL n=5 Participants
Beta-2 microglobulin at baseline (in mg/L)	4.1 mg/dL n=5 Participants
lactage dehydrogenase at baseline (U/L)	177 U/L n=5 Participants
Durie-Salmon Classification 1 (a or b)	0 participants n=5 Participants
Durie-Salmon Classification 2a	3 participants n=5 Participants
Durie-Salmon Classification 2b	1 participants n=5 Participants
Durie-Salmon Classification 3a	1 participants n=5 Participants
Durie-Salmon Classification 3b	0 participants n=5 Participants
International Staging System Classification I	0 participants n=5 Participants
International Staging System Classification II	3 participants n=5 Participants
International Staging System Classification III	2 participants n=5 Participants
Immunoglobulins IgG lambda Myeloma	2 participants n=5 Participants
Immunoglobulins Free Kappa light Chain Myeloma	3 participants n=5 Participants

PRIMARY outcome

Timeframe: The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks

Outcome measures

Outcome measures
Measure	DexTR (All Patients) n=5 Participants All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
Effect of Drug Combination on Multiple Myeloma partial response (PR)	2 participants
Effect of Drug Combination on Multiple Myeloma minimal response (MR)	1 participants
Effect of Drug Combination on Multiple Myeloma progression of disease	2 participants

Adverse Events

DexTR (All Patients)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DexTR (All Patients) n=5 participants at risk All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
Infections and infestations sepsis	20.0% 1/5
Infections and infestations Fever	20.0% 1/5
Cardiac disorders Cardiac Arrythmia	20.0% 1/5

Additional Information

Jennifer Hess

Weill Cornell Medical College

Phone: 6469629440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60