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Revlimid / All-Trans Retinoic Acid (ATRA) / Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT01985477 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-09-14

No results posted yet for this study

Summary

The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of lenalidomide, all-trans retinoic acid (ATRA), and dexamethasone that can be given to patients with relapsed or refractory multiple myeloma (MM).

The goal of the Phase II portion of this study is to learn if ATRA when given in combination with lenalidomide alone or with lenalidomide and dexamethasone can help to control multiple myeloma.

In September 2015, the study was terminated due to slow accrual while still a Phase I study, no additional registration or research performed under the Phase II portion of the study.

Conditions

Interventions

DRUG

Lenalidomide

Phase I All Patients - Induction: Lenalidomide starting dose 25 mg by mouth 1 time every day on Day 1-21. Phase II Group A: Lenalidomide starting dose: Dose tolerated prior to enrollment. Maintenance Therapy: Phase I and Phase II Group A: Maintenance therapy lenalidomide at dose level tolerated at completion of cycle 3 for 21/28 days. Phase II Group B: Lenalidomide will be given as a single oral dose at the level patient was on at the time of progression on single agent lenalidomide prior to study enrollment.

DRUG

Dexamethasone

Phase I All Patients - Induction: Dexamethasone starting dose 40 mg by mouth on Days 1,8,15,22. Phase II Group A: Dexamethasone starting dose: Dose previously on when progressing prior to study entry. Maintenance Therapy: Phase I and Phase II Group A: Dexamethasone at last tolerated dose on Days 1, 8, 15 and 22.

DRUG

All-Trans Retinoic Acid (ATRA)

Phase I All Patients - Induction: ATRA starting dose 25 mg/m2 by mouth 2 times each day on Days 1-21. Phase II Group A: ATRA starting dose: MTD from Phase I. Maintenance Therapy: Phase I and Phase II Group A: ATRA at dose determined in Phase I for 14/28 days. Phase II Group B: All-Trans Retinoic Acid (ATRA) starting dose: MTD from Phase I. Maintenance Therapy Group B: ATRA at the dose determined in the Phase I portion of the trial for 14/28 days.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jatin J. Shah, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01985477 on ClinicalTrials.gov